Single and Multiple Ascending Dose Study of KN-002
- Registration Number
- NCT05006521
- Lead Sponsor
- Kinaset Therapeutics Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KN-002 for SAD (Part 1) KN-002 Up to 6 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002 Placebo for MAD (Part 2) KN-002 Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo Placebo for SAD (Part 1) KN-002 Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo KN-002 for MAD (Part 2) KN-002 Up to 4 cohorts with 6 of 8 subjects per cohort randomised to receive KN-002 KN-002 for Part 4 KN-002 Single cohort with up to 18 of 24 subjects randomised to active treatment Placebo for Part 4 KN-002 Single cohort with up to 6 of 24 subjects randomised to placebo treatment Placebo for Part 3 KN-002 Single cohort with up to 6 of 24 subjects randomised to placebo treatment KN-002 for Part 3 KN-002 Single cohort with up to 18 of 24 subjects randomised to active treatment
- Primary Outcome Measures
Name Time Method Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events 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 Outcome Measures
Name Time Method Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC) Day 1 to 17 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) Day 1 to 17 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 Day 1 to 17 Change of fractional exhaled nitric oxide (FeNO) levels after repeated dosing to patients with mild asthma, moderate to severe asthma and COPD
Trial Locations
- Locations (1)
Medicines Evaluation Unit
🇬🇧Manchester, United Kingdom