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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Kinaset Therapeutics Inc
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo for SAD (Part 1)
Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo
Intervention: KN-002 (Drug)
KN-002 for SAD (Part 1)
Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002
Intervention: KN-002 (Drug)
KN-002 for MAD (Part 2)
Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002
Intervention: KN-002 (Drug)
Placebo for MAD (Part 2)
Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo
Intervention: KN-002 (Drug)
KN-002 for Part 3
Single cohort with up to 18 of 24 subjects randomised to active treatment
Intervention: KN-002 (Drug)
Placebo for Part 3
Single cohort with up to 6 of 24 subjects randomised to placebo treatment
Intervention: KN-002 (Drug)
KN-002 for Part 4
Single cohort with up to 18 of 24 subjects randomised to active treatment
Intervention: KN-002 (Drug)
Placebo for Part 4
Single cohort with up to 6 of 24 subjects randomised to placebo treatment
Intervention: KN-002 (Drug)
Outcomes
Primary Outcomes
Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
Time Frame: Day 1 to 17
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 Outcomes
- Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)(Day 1 to 17)
- Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)(Day 1 to 17)
- Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels(Day 1 to 17)