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Single and Multiple Ascending Dose Study of KN-002 (KN-002)

Primary Purpose

Asthma COPD

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
KN-002
Sponsored by
Kinaset Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma COPD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female, 18 - 55 years old
  • Willing and able to give informed consent and comply with the study
  • Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
  • Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
  • Pre-bronchodilator FEV1 ≥ 70 and ≥80% for Part 1 and Part 2 participants, respectively
  • Pre-Bronchodilator FEV1 ≥50% predicted and ≤100% for Part 3
  • Post Bronchodilator FEV1 ≥40 and ≤ 85% for Part 4

Exclusion Criteria:

  • Clinically significant laboratory test abnormalities
  • Clinically significant abnormal blood pressure and/or pulse rate
  • Resting ECG clinically significant abnormalities
  • Respiratory tract infection within 6 weeks of screening
  • Positive test for active COVID-19 within 2 days prior to administration of IMP

Sites / Locations

  • Medicines Evaluation UnitRecruiting

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

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

KN-002 for SAD (Part 1)

Placebo for SAD (Part 1)

KN-002 for MAD (Part 2)

Placebo for MAD (Part 2)

KN-002 for Part 3

Placebo for Part 3

KN-002 for Part 4

Placebo for Part 4

Arm Description

Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002

Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo

Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002

Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo

Single cohort with up to 18 of 24 subjects randomised to active treatment

Single cohort with up to 6 of 24 subjects randomised to placebo treatment

Single cohort with up to 18 of 24 subjects randomised to active treatment

Single cohort with up to 6 of 24 subjects randomised to placebo treatment

Outcomes

Primary Outcome Measures

Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
To assess the safety and tolerability of KN-002 via the assessment of the number, severity and type of treatment emergent adverse events post single and repeat dose administration to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD

Secondary Outcome Measures

Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)
KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:
Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)
KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:
Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels
Change of fractional exhaled nitric oxide (FeNO) levels after repeated dosing to patients with mild asthma, moderate to severe asthma and COPD

Full Information

First Posted
July 30, 2021
Last Updated
August 30, 2022
Sponsor
Kinaset Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05006521
Brief Title
Single and Multiple Ascending Dose Study of KN-002
Acronym
KN-002
Official Title
Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, PK, and PD of Single Ascending Doses of KN-002 in Healthy Subjects and Multiple Ascending Doses of KN-002 in Subjects With Mild Asthma, Moderate-Severe Asthma and COPD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
April 28, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinaset Therapeutics Inc

4. Oversight

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

5. Study Description

Brief Summary
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KN-002 for SAD (Part 1)
Arm Type
Experimental
Arm Description
Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002
Arm Title
Placebo for SAD (Part 1)
Arm Type
Placebo Comparator
Arm Description
Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo
Arm Title
KN-002 for MAD (Part 2)
Arm Type
Experimental
Arm Description
Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002
Arm Title
Placebo for MAD (Part 2)
Arm Type
Experimental
Arm Description
Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo
Arm Title
KN-002 for Part 3
Arm Type
Experimental
Arm Description
Single cohort with up to 18 of 24 subjects randomised to active treatment
Arm Title
Placebo for Part 3
Arm Type
Experimental
Arm Description
Single cohort with up to 6 of 24 subjects randomised to placebo treatment
Arm Title
KN-002 for Part 4
Arm Type
Experimental
Arm Description
Single cohort with up to 18 of 24 subjects randomised to active treatment
Arm Title
Placebo for Part 4
Arm Type
Experimental
Arm Description
Single cohort with up to 6 of 24 subjects randomised to placebo treatment
Intervention Type
Drug
Intervention Name(s)
KN-002
Intervention Description
KN-002 dry powder inhaler
Primary Outcome Measure Information:
Title
Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
Description
To assess the safety and tolerability of KN-002 via the assessment of the number, severity and type of treatment emergent adverse events post single and repeat dose administration to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD
Time Frame
Day 1 to 17
Secondary Outcome Measure Information:
Title
Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)
Description
KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:
Time Frame
Day 1 to 17
Title
Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)
Description
KN-002 pharmacokinetics after single and repeat dosing to healthy volunteers and patients with mild asthma, moderate to severe asthma and COPD:
Time Frame
Day 1 to 17
Title
Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels
Description
Change of fractional exhaled nitric oxide (FeNO) levels after repeated dosing to patients with mild asthma, moderate to severe asthma and COPD
Time Frame
Day 1 to 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female, 18 - 55 years old Willing and able to give informed consent and comply with the study Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method Pre-bronchodilator FEV1 ≥ 70 and ≥80% for Part 1 and Part 2 participants, respectively Pre-Bronchodilator FEV1 ≥50% predicted and ≤100% for Part 3 Post Bronchodilator FEV1 ≥40 and ≤ 85% for Part 4 Exclusion Criteria: Clinically significant laboratory test abnormalities Clinically significant abnormal blood pressure and/or pulse rate Resting ECG clinically significant abnormalities Respiratory tract infection within 6 weeks of screening Positive test for active COVID-19 within 2 days prior to administration of IMP
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frazer Morgan
Phone
+44 (0)7841 278534
Email
frazer.morgan@kinasettx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Singh
Organizational Affiliation
Medicines Evaluation Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Singh
Phone
+44 (0)161 946 1459
Email
enquiries@meu.org.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Kinaset Therapeutics Inc. will not disclose individual subject de-identified study data

Learn more about this trial

Single and Multiple Ascending Dose Study of KN-002

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