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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma COPD
• Intervention / Treatment: Drug: KN-002

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Frazer Morgan; Phone Number: +44 (0)7841 278534; Email: frazer.morgan@kinasettx.com

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • Medicines Evaluation Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KN-002 for SAD (Part 1); Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002	Drug: KN-002; KN-002 dry powder inhaler
Placebo Comparator: Placebo for SAD (Part 1); Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo	Drug: KN-002; KN-002 dry powder inhaler
Experimental: KN-002 for MAD (Part 2); Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002	Drug: KN-002; KN-002 dry powder inhaler
Experimental: Placebo for MAD (Part 2); Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo	Drug: KN-002; KN-002 dry powder inhaler
Experimental: KN-002 for Part 3; Single cohort with up to 18 of 24 subjects randomised to active treatment	Drug: KN-002; KN-002 dry powder inhaler
Experimental: Placebo for Part 3; Single cohort with up to 6 of 24 subjects randomised to placebo treatment	Drug: KN-002; KN-002 dry powder inhaler
Experimental: KN-002 for Part 4; Single cohort with up to 18 of 24 subjects randomised to active treatment	Drug: KN-002; KN-002 dry powder inhaler
Experimental: Placebo for Part 4; Single cohort with up to 6 of 24 subjects randomised to placebo treatment	Drug: KN-002; KN-002 dry powder inhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 to 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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:	Day 1 to 17
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:	Day 1 to 17
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	Day 1 to 17

Collaborators and Investigators

• Sponsor: Kinaset Therapeutics Inc
• Investigators: Principal Investigator: David Singh, Medicines Evaluation Unit

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): December 20, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 8, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: KN-002/1/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Kinaset Therapeutics Inc. will not disclose individual subject de-identified study data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No