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Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers

Primary Purpose

Covid19

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

UNI911 inhalation 1% and intranasal spray 1%

Placebo

About this trial

This is an interventional other trial for Covid19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (main ones):

Signed Informed Consent Form (ICF)
Male or non-pregnant and non-lactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test prior to dosing. (Women who are postmenopausal or who had tubal ligation/hysterectomy do not need to have a pregnancy test done and do not need to agree to use contraception.)
ECG without clinically significant abnormalities (including QTcF < 450 ms)
Age ≥ 18 and < 65 years at the time of signing ICF
Normally active and in good health by medical history and physical examination
Minimum 80% of predicted lung function, including FEV1 after beta2-agonist, TLC, DCO, and CPET with pulse oximetry
Chest X-ray without clinically significant abnormalities

Exclusion Criteria (main ones):

Enrollment in an UNI911 study in the previous 6 months
Clinically significant allergy (as judged by the investigator) or history of significant adverse reaction to niclosamide or related compounds, to any of the excipients used.
Underlying condition that may interfere with inhalation of the IP
Current acute or chronic condition (incl. COPD, asthma, or other severe respiratory disease, CV disease, diabetes mellitus, obesity, malignant and autoimmune diseases) unless considered clinically irrelevant and stable by the investigator
Renal impairment (eGFR < 60 mL/min/1.73m2) or hepatic impairment (as judged by the investigator)

Sites / Locations

DanTrials ApS

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

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Placebo (applicable for cohorts 1-5)

Arm Description

Single dose of UNI911 inhalation (4 mL 0.1% ~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)

Single dose of UNI911 inhalation (1 mL 1% ~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)

Single dose of UNI911 inhalation (3 mL 1% ~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)

Single dose of UNI911 inhalation (6 mL 1% ~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)

UNI911 inhalation (6 mL 1% ~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 2,5 days.

UNI911 inhalation (1 mL 1% ~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 6,5 days.

UNI911 inhalation (3 mL 1% ~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 6,5 days.

Placebo, administered in a double-blinded fashion (except for the first subjects of cohorts 1-4) at the same dose and frequency as UNI911 inhalation and intranasal spray.

Outcomes

Primary Outcome Measures

Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency

AE frequency in each cohort and treatment group

Secondary Outcome Measures

Full Information

NCT ID

NCT04576312

First Posted

September 28, 2020

Last Updated

August 20, 2021

Sponsor

UNION therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04576312

Brief Title

Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers

Official Title

Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults With COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

June 29, 2020 (Actual)

Primary Completion Date

December 4, 2020 (Actual)

Study Completion Date

December 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNION therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed Description

This is a Phase 1 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety of Ascending Doses of UNI911 INHALATION in Healthy Volunteers in Preparation for Evaluation in Adults with COVID-19 64 subjects will be sequentially enrolled to receive dosage of UNI911 INHALATION or placebo. 4 sentinel subjects (one per cohort 1, 2 ,3 and 4 ) will be treated in an open-label manner to confirm the safety of each dose sequentially. 40 subjects will be randomly assigned (3:1) to either active or placebo. For the last 2 cohorts, a total of 20 healthy volunteers will be enrolled to receive multiple doses of UNI911 INHALATION.

6. Conditions and Keywords

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

Covid19

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Single dose of UNI911 inhalation (4 mL 0.1% ~ 3,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Single dose of UNI911 inhalation (1 mL 1% ~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Single dose of UNI911 inhalation (3 mL 1% ~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

Single dose of UNI911 inhalation (6 mL 1% ~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg)

Arm Title

Cohort 5

Arm Type

Experimental

Arm Description

UNI911 inhalation (6 mL 1% ~ 50,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 2,5 days.

Arm Title

Cohort 6

Arm Type

Experimental

Arm Description

UNI911 inhalation (1 mL 1% ~ 8,4 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 6,5 days.

Arm Title

Cohort 7

Arm Type

Experimental

Arm Description

UNI911 inhalation (3 mL 1% ~ 25,2 mg) and intranasal spray (2 x 150 µL, 1% ~ 2,5 mg) BID for 6,5 days.

Arm Title

Placebo (applicable for cohorts 1-5)

Arm Type

Placebo Comparator

Arm Description

Placebo, administered in a double-blinded fashion (except for the first subjects of cohorts 1-4) at the same dose and frequency as UNI911 inhalation and intranasal spray.

Intervention Type

Drug

Intervention Name(s)

UNI911 inhalation 1% and intranasal spray 1%

Intervention Description

Niclosamide is a broad spectrum, host tageting antiviral that inhibits viral replication (by neutralizing endosomal pH) and increases viral clearance (by increasing the autophagic flux). The niclosamide 1% solution is administered as inhalation by nebulization and intranasal by a nasal spray.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

The placebo formulation contains the vehicle. The solution is administered in the same way as the active drug. Placebo was only administered for cohorts 1-5.

Primary Outcome Measure Information:

Title

Assess safety of UNI911 INHALATION in healthy volunteers: AE frequency

Description

AE frequency in each cohort and treatment group

Time Frame

Up to Day 6

Other Pre-specified Outcome Measures:

Title

Pharmacokinetic Parameters: Cmax

Description

Maximum concentration of active drug molecules in blood (Cmax)

Time Frame

Up to Day 4 of participant treatment

Title

Pharmacokinetic Parameters: Tmax

Description

Time to reach maximum level (Tmax)

Time Frame

Up to Day 4 of participant treatment

Title

Pharmacokinetic Parameters: AUC

Description

Area Under the Curve of drug level in blood versus time (AUC)

Time Frame

Up to Day 4 of participant treatment

Title

Pharmacokinetic Parameters: Half life

Description

Half life

Time Frame

Up to Day 4 of participant treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (main ones): Signed Informed Consent Form (ICF) Male or non-pregnant and non-lactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test prior to dosing. (Women who are postmenopausal or who had tubal ligation/hysterectomy do not need to have a pregnancy test done and do not need to agree to use contraception.) ECG without clinically significant abnormalities (including QTcF < 450 ms) Age ≥ 18 and < 65 years at the time of signing ICF Normally active and in good health by medical history and physical examination Minimum 80% of predicted lung function, including FEV1 after beta2-agonist, TLC, DCO, and CPET with pulse oximetry Chest X-ray without clinically significant abnormalities Exclusion Criteria (main ones): Enrollment in an UNI911 study in the previous 6 months Clinically significant allergy (as judged by the investigator) or history of significant adverse reaction to niclosamide or related compounds, to any of the excipients used. Underlying condition that may interfere with inhalation of the IP Current acute or chronic condition (incl. COPD, asthma, or other severe respiratory disease, CV disease, diabetes mellitus, obesity, malignant and autoimmune diseases) unless considered clinically irrelevant and stable by the investigator Renal impairment (eGFR < 60 mL/min/1.73m2) or hepatic impairment (as judged by the investigator)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jesper Sonne, MD, DMSci

Organizational Affiliation

Dantrials Aps

Official's Role

Principal Investigator

Facility Information:

Facility Name

DanTrials ApS

City

Copenhagen

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers

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