Overview

Single and Multiple Ascending Dose Study of KN-002

Status:
Recruiting
Trial end date:
2022-05-30
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Kinaset Therapeutics Inc
Criteria
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

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