A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
Trial Parameters
Brief Summary
This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled.
Eligibility Criteria
Inclusion Criteria: 1. Participant is overtly healthy or has no clinically significant condition as determined by PI/Sub-Investigator including medical history, vital signs, ECG, laboratory tests, and physical examination at Screening and admission (Day -2 and Day -1). 2. Participant has normal lung function assessment with FEV1 of at least 80% of the predicted value and FEV1/FVC ratio of \> 0.7 measured at Screening. 3. Availability to participate voluntarily for the entire study duration and willing to adhere to all protocol requirements. 4. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent. 5. Male participant with body weight of ≥ 50.0 kg, female participant with body weight ≥ 45.0 kg; males or females with body mass index (BMI) of ≥ 18 to \< 30.0 kg/m² at screening. 6. Female participants of childbearing potential must have a negative serum pregnancy test result at Screening and a negative pregnancy test result at Baseline and agree t