Single and Multiple Ascending Dose Study of KN-002 (NCT05006521) | Clinical Trial Compass
CompletedPhase 1
Single and Multiple Ascending Dose Study of KN-002
United Kingdom117 participantsStarted 2021-07-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since KN-002 was tested in a Phase 1 trial focused mainly on safety, what do we know so far about whether it caused any concerning side effects in participants with asthma or COPD?
2Now that this trial is completed, has any data been published or shared about how safe and well-tolerated KN-002 turned out to be, and does that affect whether you'd recommend I consider it or a future related study?
3Because this was an early-phase dose-escalation study rather than a treatment effectiveness trial, how does that limit what we can actually conclude about whether KN-002 might help manage my asthma or COPD?
4Given that this specific trial is now closed to enrollment, are there any follow-on Phase 2 studies of KN-002 that might be worth looking into, or would sticking with my current standard treatment be the more sensible path right now?
5How does what was learned in this KN-002 safety study compare to the evidence behind the treatments I'm already on, so I can put the risk-benefit picture in perspective?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events