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Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175

Primary Purpose

Refractory Chronic Cough

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
3 mg NOC-100 (via nebulizer)
1 mg NOC-110 (via DPI) [1x 1 mg capsule]
3 mg NOC-110 (via DPI)
Placebo (via DPI)
6 mg NOC-110 (via DPI)
Placebo (via DPI) [2x Placebo capsules]
Sponsored by
Nocion Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Chronic Cough

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participants must meet all of the following criteria to be eligible for participation in the study: Male or female participants between the ages of 18 to 65 years, inclusive, at the time of screening (Part 1) and between the ages of 18 to 85 years, inclusive, at the time of screening (Part 2). Has had rCC diagnosis for ≥ 12 months (Part 2) prior to screening. Awake-cough frequency of ≥20 per hour (average) at Screening (Part 2). Score of ≥40 mm on the Cough Severity Visual Analog Scale (VAS) at Screening (Part 2). Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the rCC. (Part 2) Body mass index (BMI) ≥19.0 and ≤32.0 kg/m2, inclusive, at Screening. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2 x upper limit of normal (ULN); alkaline phosphatase (ALP) and bilirubin ≤1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Creatinine clearance ≥50 mL/min. Must be fully SARS-CoV-2 vaccinated. Must be SARS-CoV-2 negative via rapid antigen testing or polymerase chain reaction (PCR) test at Screening and PCR at Check-in Day -1. In the Investigator's opinion, has no clinically significant disease and/or clinically significant abnormal laboratory values as determined by the Investigator based on medical history, physical examination, or laboratory evaluations conducted at the screening visit or on admission to the clinical research unit. Exclusion Criteria: Participants who meet any one of the following criteria will be deemed ineligible for participation in the study: Is found to have positive test for SARS-CoV-2 at Screening or Check-in Day -1, whether or not this was accompanied by the clinical symptoms of COVID-19. Current smoker or individuals who have given up smoking within the past 6 months prior to screening, or those with >20 pack-year smoking history (Part 2) Current diagnosis of chronic obstructive pulmonary disease (COPD), bronchiectasis, unexplained pulmonary fibrosis, or asthma (Part 2). History or presence of alcohol or drug use disorder, per Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), within the past 2 years prior to screening. Current opiate/opioid use in the past 7 days prior to screening, or medical history of opiate/opioid use disorder. Unable to refrain from the use of: Gabapentin, pregabalin, and/or amitryptline or other tricyclics within 4 weeks prior to screening and throughout the study (Part 2) Chronic, systemic corticosteroid use within 4 weeks prior to screening and throughout the study (Part 2). Inhalers including long-acting and short acting beta 2-agonists (LABA and SABA), and inhaled corticosteroids (ICS) within 8 weeks prior to screening and throughout the study. Lidocaine or related compounds of any form within 14 days prior to screening and throughout the study (Part 2). Medication or remedies to aid sleeping 14 days prior to screening and throughout the study (Part 2). Angiotensin-converting enzyme (ACE)-inhibitor within 12 weeks prior to screening and throughout the study (Part 2). Antitussives 7 days prior to screening and throughout the study (Part 2). Speech and language therapy for rCC within 4 weeks prior to screening and throughout the study (Part 2). Food and beverages containing alcohol for 24 hours prior to screening (Part 2). History or presence of cardiac dysfunction including arrhythmia, bundle branch block; Wolff Parkinson White syndrome, recent thromboembolic event, prolonged PR (≥220 msec), QRS (≥120 msec), QTcF interval (≥450 msec [males] or ≥470 msec [females]) or has ECG findings deemed abnormal with clinical significance by the Investigator or designee at Screening. Positive results at Screening for HIV, HBsAg, or HCV (participants successfully treated for HCV may be permitted at the discretion of the Investigator). Supine blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg (Part 1), or greater than 160/95 mmHg (Part 2) at Screening. Vital signs may be repeated twice. Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening. Vital signs may be repeated twice. History of asthma or COPD (Part 1). Forced expiratory volume in 1 second/ forced vital capacity (FEV1/FVC) < lower limit of normal (LLN) per Global Lung Health Initiative normative dataset at Screening. Had symptoms of any significant acute illness, including symptoms of COVID-19 within 30 days before the start of the study (time of first dose), as determined by the Investigator.

Sites / Locations

  • Celerion
  • Clinical Site Partners
  • Clinical Site Partners

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Part 1-Period 1-Treatment A

Part 1-Periods 2 through 4 -Treatment B

Part 1-Periods 2 through 4 - Treatment C

Part 1-Periods 2 through 4- Placebo

Part 1-Period 5- Treatment D

Part 1-Period 5- Placebo

Part 2- Active

Part 2- Placebo

Arm Description

3 mg NOC-100 (via nebulizer)

1 mg NOC-110 DPI (1 capsule)

3mg NOC-110 DPI (1 capsule)

Placebo (1 capsule)

6mg NOC-110 DPI (2 capsules)

Placebo (2 capsules)

6mg NOC-110 DPI (2 capsules)

Placebo DPI (2 capsules)

Outcomes

Primary Outcome Measures

Number and severity of Treatment Emergent Adverse Events (TEAEs) following single doses of NOC-110 or placebo administered with a DPI
To evaluate the safety and tolerability of single doses of three dose levels of NTX-1175 drug substance administered by DPI (Drug Product NOC-110) compared to a single dose reference nebulizer treatment (Drug Product NOC-100) in healthy participants, number and severity of TEAEs following single doses of NOC-110 or placebo administered with a DPI compared to a reference period administration of NOC 100 via a nebulizer in healthy adult participants will be reported.
Number and severity of TEAE following repeat doses of NOC 110 compared to placebo in participants with chronic cough.
To evaluate the safety and tolerability of multiple doses of NOC-110 administered by DPI to participants with refractory chronic cough (rCC), number and severity of TEAE following repeat doses of NOC 110 compared to placebo in participants with chronic cough will be reported.

Secondary Outcome Measures

Peak plasma concentration (Cmax) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175: Cmax
The time to reach maximum observed concentration (Tmax) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175: Tmax
The area under the concentration-time (AUC) curve of single doses of three dose levels of NOC-110 compared to a single dose reference nebulizer treatment in healthy participants.
PK parameters for plasma NTX-1175: AUC [time 0 to the last observed non-zero concentration (t) (AUC0-t), time 0 to Hour 24 (AUC0-24), time 0 extrapolated to infinity (AUC0-inf), percent of AUC0 inf extrapolated (AUC%extrap)]
The time of the last measurable concentration (Tlast) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175: Tlast
The apparent terminal elimination half-life (t½) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175: t½
The apparent terminal elimination rate constant (Kel) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175: Kel
The Cmax of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: Cmax and maximum observed concentration at steady-state (Cmax, ss)
The Tmax of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: Tmax, time to reach Cmax,ss (Tmax,ss)
The AUC of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: AUC0-t AUC0-inf AUC%extrap
The Tlast of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: Tlast
The t½ of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: t½
The Kel multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: Kel
The concentration observed at the end of the dosing interval (Ctrough) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: Ctrough
The minimum observed non zero concentration between dose time and dose time + dosing interval (tau) (min,ss,) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: Cmin,ss
The area under the concentration-time curve during a dosing interval (tau), at steady state (AUCtau) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: AUCtau
The average concentration during a dosing interval, at steady state (Cavg,ss) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: Cavg,ss
The accumulation (R) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175: R
Awake-coughs per hour in participants with rCC
The treatment effect of multiple doses of one dose level of NOC-110 administered by DPI, as determined by awake-coughs per hour in participants with rCC.

Full Information

First Posted
November 2, 2022
Last Updated
March 29, 2023
Sponsor
Nocion Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05628740
Brief Title
Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
Official Title
A Phase 1, Two Part, Placebo-controlled, Single Dose Study in Healthy Volunteers and Multiple Dose Study in Patients With Refractory Chronic Cough to Assess the Safety, Tolerability, and PK of NTX-1175 Administered Via Nebulizer (NOC-100) and Dry Powder Inhaler (NOC-110)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nocion Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Part 1 will evaluate the safety, tolerability and PK of single doses of three dose levels of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) compared to a single dose reference nebulizer (NOC-100) treatment in healthy participants. Part 2 will evaluate the safety, tolerability and PK of multiple doses of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) to participants with refractory chronic cough. Part 2 will also evaluate the treatment effect of multiple doses of one dose level of NTX-1175 drug substance administered by dry powder inhaler (NOC-110).
Detailed Description
Part 1 is a randomized, double-blinded 3 period crossover and 1 period parallel study of single dose administration of NOC-110 via dry powder inhaler, preceded by a reference period of NOC-100 administered via nebulizer. A total of 12 healthy participants will be enrolled to ensure that 9 participants complete this part of study. Part 2 is a randomized, double-blinded, placebo-controlled, multiple-dose, parallel design study in patients with refractory chronic cough. A total of 12 participants will be enrolled to ensure that 8 participants complete this part of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Part 1: randomized, double-blind, placebo-controlled, 3-period crossover, and 1-period parallel study. Part 2: randomized, double-blind, placebo-controlled, multiple-dose, parallel-design.
Masking
ParticipantInvestigator
Masking Description
A computerized randomization scheme for Part 1 and Part 2 will be created by a blinded study statistician and it shall be considered blinded per the following: The randomization is available only to the unblinded Clinic pharmacy staff who are preparing the study drug and who will not be involved in any other aspect of the study including administration of the study drug. The randomization scheme will not be made available to the Sponsor, study participants, or members of the staff responsible for the monitoring and evaluation of safety assessments.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1-Period 1-Treatment A
Arm Type
Experimental
Arm Description
3 mg NOC-100 (via nebulizer)
Arm Title
Part 1-Periods 2 through 4 -Treatment B
Arm Type
Placebo Comparator
Arm Description
1 mg NOC-110 DPI (1 capsule)
Arm Title
Part 1-Periods 2 through 4 - Treatment C
Arm Type
Placebo Comparator
Arm Description
3mg NOC-110 DPI (1 capsule)
Arm Title
Part 1-Periods 2 through 4- Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (1 capsule)
Arm Title
Part 1-Period 5- Treatment D
Arm Type
Placebo Comparator
Arm Description
6mg NOC-110 DPI (2 capsules)
Arm Title
Part 1-Period 5- Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (2 capsules)
Arm Title
Part 2- Active
Arm Type
Placebo Comparator
Arm Description
6mg NOC-110 DPI (2 capsules)
Arm Title
Part 2- Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo DPI (2 capsules)
Intervention Type
Drug
Intervention Name(s)
3 mg NOC-100 (via nebulizer)
Intervention Description
Participants determined to be eligible for Part 1 of the study will be enrolled and will be assigned to receive a single dose of the reference nebulizer treatment of NOC 100 at 3 mg (Treatment A) in Period 1
Intervention Type
Drug
Intervention Name(s)
1 mg NOC-110 (via DPI) [1x 1 mg capsule]
Intervention Description
Participants will be randomized to receive single doses of 1 mg NOC-110 (via DPI) in a crossover fashion according to a prespecified randomization schedule
Intervention Type
Drug
Intervention Name(s)
3 mg NOC-110 (via DPI)
Intervention Description
Participants will be randomized to receive single doses of 3 mg NOC-110 (via DPI) in a crossover fashion according to a prespecified randomization schedule
Intervention Type
Drug
Intervention Name(s)
Placebo (via DPI)
Intervention Description
Participants will be randomized to receive single doses of placebo via capsule in a crossover fashion according to a prespecified randomization schedule
Intervention Type
Drug
Intervention Name(s)
6 mg NOC-110 (via DPI)
Intervention Description
Participants will be randomized to receive single doses of 6 mg NOC-110 via DPI in a parallel fashion according to a prespecified randomization schedule
Intervention Type
Drug
Intervention Name(s)
Placebo (via DPI) [2x Placebo capsules]
Intervention Description
Participants will be randomized to receive single doses of Placebo (via DPI) [2x Placebo capsules] in a parallel fashion according to a prespecified randomization schedule
Primary Outcome Measure Information:
Title
Number and severity of Treatment Emergent Adverse Events (TEAEs) following single doses of NOC-110 or placebo administered with a DPI
Description
To evaluate the safety and tolerability of single doses of three dose levels of NTX-1175 drug substance administered by DPI (Drug Product NOC-110) compared to a single dose reference nebulizer treatment (Drug Product NOC-100) in healthy participants, number and severity of TEAEs following single doses of NOC-110 or placebo administered with a DPI compared to a reference period administration of NOC 100 via a nebulizer in healthy adult participants will be reported.
Time Frame
Part 1- Screening through Day 23
Title
Number and severity of TEAE following repeat doses of NOC 110 compared to placebo in participants with chronic cough.
Description
To evaluate the safety and tolerability of multiple doses of NOC-110 administered by DPI to participants with refractory chronic cough (rCC), number and severity of TEAE following repeat doses of NOC 110 compared to placebo in participants with chronic cough will be reported.
Time Frame
Part 2- Screening through Day 12
Secondary Outcome Measure Information:
Title
Peak plasma concentration (Cmax) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Description
PK parameters for plasma NTX-1175: Cmax
Time Frame
Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
Title
The time to reach maximum observed concentration (Tmax) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Description
PK parameters for plasma NTX-1175: Tmax
Time Frame
Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
Title
The area under the concentration-time (AUC) curve of single doses of three dose levels of NOC-110 compared to a single dose reference nebulizer treatment in healthy participants.
Description
PK parameters for plasma NTX-1175: AUC [time 0 to the last observed non-zero concentration (t) (AUC0-t), time 0 to Hour 24 (AUC0-24), time 0 extrapolated to infinity (AUC0-inf), percent of AUC0 inf extrapolated (AUC%extrap)]
Time Frame
Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
Title
The time of the last measurable concentration (Tlast) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Description
PK parameters for plasma NTX-1175: Tlast
Time Frame
Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
Title
The apparent terminal elimination half-life (t½) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Description
PK parameters for plasma NTX-1175: t½
Time Frame
Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
Title
The apparent terminal elimination rate constant (Kel) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Description
PK parameters for plasma NTX-1175: Kel
Time Frame
Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
Title
The Cmax of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: Cmax and maximum observed concentration at steady-state (Cmax, ss)
Time Frame
Part 2- Day 1, Day 5
Title
The Tmax of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: Tmax, time to reach Cmax,ss (Tmax,ss)
Time Frame
Part 2- Day 1, Day 5
Title
The AUC of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: AUC0-t AUC0-inf AUC%extrap
Time Frame
Part 2- Day 1, Day 5
Title
The Tlast of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: Tlast
Time Frame
Part 2- Day 1, Day 5
Title
The t½ of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: t½
Time Frame
Part 2- Day 1, Day 5
Title
The Kel multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: Kel
Time Frame
Part 2- Day 1, Day 5
Title
The concentration observed at the end of the dosing interval (Ctrough) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: Ctrough
Time Frame
Part 2- Days 2 to 4
Title
The minimum observed non zero concentration between dose time and dose time + dosing interval (tau) (min,ss,) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: Cmin,ss
Time Frame
Part 2- Day 5
Title
The area under the concentration-time curve during a dosing interval (tau), at steady state (AUCtau) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: AUCtau
Time Frame
Part 2- Day 5
Title
The average concentration during a dosing interval, at steady state (Cavg,ss) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: Cavg,ss
Time Frame
Part 2- Day 5
Title
The accumulation (R) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Description
PK parameters for plasma NTX-1175: R
Time Frame
Part 2- Day 5
Title
Awake-coughs per hour in participants with rCC
Description
The treatment effect of multiple doses of one dose level of NOC-110 administered by DPI, as determined by awake-coughs per hour in participants with rCC.
Time Frame
Part 2- Screening, Day -1, Day 1, Day 3 and Day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for participation in the study: Male or female participants between the ages of 18 to 65 years, inclusive, at the time of screening (Part 1) and between the ages of 18 to 85 years, inclusive, at the time of screening (Part 2). Has had rCC diagnosis for ≥ 12 months (Part 2) prior to screening. Awake-cough frequency of ≥20 per hour (average) at Screening (Part 2). Score of ≥40 mm on the Cough Severity Visual Analog Scale (VAS) at Screening (Part 2). Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the rCC. (Part 2) Body mass index (BMI) ≥19.0 and ≤32.0 kg/m2, inclusive, at Screening. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2 x upper limit of normal (ULN); alkaline phosphatase (ALP) and bilirubin ≤1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). Creatinine clearance ≥50 mL/min. Must be fully SARS-CoV-2 vaccinated. Must be SARS-CoV-2 negative via rapid antigen testing or polymerase chain reaction (PCR) test at Screening and PCR at Check-in Day -1. In the Investigator's opinion, has no clinically significant disease and/or clinically significant abnormal laboratory values as determined by the Investigator based on medical history, physical examination, or laboratory evaluations conducted at the screening visit or on admission to the clinical research unit. Exclusion Criteria: Participants who meet any one of the following criteria will be deemed ineligible for participation in the study: Is found to have positive test for SARS-CoV-2 at Screening or Check-in Day -1, whether or not this was accompanied by the clinical symptoms of COVID-19. Current smoker or individuals who have given up smoking within the past 6 months prior to screening, or those with >20 pack-year smoking history (Part 2) Current diagnosis of chronic obstructive pulmonary disease (COPD), bronchiectasis, unexplained pulmonary fibrosis, or asthma (Part 2). History or presence of alcohol or drug use disorder, per Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), within the past 2 years prior to screening. Current opiate/opioid use in the past 7 days prior to screening, or medical history of opiate/opioid use disorder. Unable to refrain from the use of: Gabapentin, pregabalin, and/or amitryptline or other tricyclics within 4 weeks prior to screening and throughout the study (Part 2) Chronic, systemic corticosteroid use within 4 weeks prior to screening and throughout the study (Part 2). Inhalers including long-acting and short acting beta 2-agonists (LABA and SABA), and inhaled corticosteroids (ICS) within 8 weeks prior to screening and throughout the study. Lidocaine or related compounds of any form within 14 days prior to screening and throughout the study (Part 2). Medication or remedies to aid sleeping 14 days prior to screening and throughout the study (Part 2). Angiotensin-converting enzyme (ACE)-inhibitor within 12 weeks prior to screening and throughout the study (Part 2). Antitussives 7 days prior to screening and throughout the study (Part 2). Speech and language therapy for rCC within 4 weeks prior to screening and throughout the study (Part 2). Food and beverages containing alcohol for 24 hours prior to screening (Part 2). History or presence of cardiac dysfunction including arrhythmia, bundle branch block; Wolff Parkinson White syndrome, recent thromboembolic event, prolonged PR (≥220 msec), QRS (≥120 msec), QTcF interval (≥450 msec [males] or ≥470 msec [females]) or has ECG findings deemed abnormal with clinical significance by the Investigator or designee at Screening. Positive results at Screening for HIV, HBsAg, or HCV (participants successfully treated for HCV may be permitted at the discretion of the Investigator). Supine blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg (Part 1), or greater than 160/95 mmHg (Part 2) at Screening. Vital signs may be repeated twice. Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening. Vital signs may be repeated twice. History of asthma or COPD (Part 1). Forced expiratory volume in 1 second/ forced vital capacity (FEV1/FVC) < lower limit of normal (LLN) per Global Lung Health Initiative normative dataset at Screening. Had symptoms of any significant acute illness, including symptoms of COVID-19 within 30 days before the start of the study (time of first dose), as determined by the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Silber, MD
Organizational Affiliation
Nocion Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Celerion
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Clinical Site Partners
City
Leesburg
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Clinical Site Partners
City
Winter Park
State/Province
Florida
ZIP/Postal Code
34748
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175

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