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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo for SAD (Part 1)
Up to 6 cohorts with 2 of 8 subjects per cohort randomised to receive placebo
干预措施: 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
干预措施: 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
干预措施: KN-002 (Drug)
Placebo for MAD (Part 2)
Up to 4 cohorts with 2 of 8 subjects per cohort randomised to receive placebo
干预措施: KN-002 (Drug)
KN-002 for Part 3
Single cohort with up to 18 of 24 subjects randomised to active treatment
干预措施: KN-002 (Drug)
Placebo for Part 3
Single cohort with up to 6 of 24 subjects randomised to placebo treatment
干预措施: KN-002 (Drug)
KN-002 for Part 4
Single cohort with up to 18 of 24 subjects randomised to active treatment
干预措施: KN-002 (Drug)
Placebo for Part 4
Single cohort with up to 6 of 24 subjects randomised to placebo treatment
干预措施: KN-002 (Drug)
结局指标
主要结局
Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
时间窗: 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
次要结局
- 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)