NCT05006521CompletedPhase 1
Single and Multiple Ascending Dose Study of 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
Source: ClinicalTrials.gov · Last updated 7 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 117 (actual)
- First submitted
- 30 Jul 2021
- Start date
- 30 Jul 2021
- Primary completion date
- 20 Dec 2023
- Lead sponsor
- Kinaset Therapeutics Inc
- Diseases
- Asthma
- NCT number
- NCT05006521
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 117
- From 30 Jul 2021 to the primary completion date, 20 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive test for active COVID-19 within 2 days prior to administration of IMP
Other illness
- Respiratory tract infection within 6 weeks of screening
Lab values
- Clinically significant laboratory test abnormalities
Other
- Clinically significant abnormal blood pressure and/or pulse rate
- Resting ECG clinically significant abnormalities
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medicines Evaluation Unit Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.