Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
Trial Parameters
Brief Summary
This is the second single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with dose level ranging from 15 μg to 30 μg.
Eligibility Criteria
Key Inclusion Criteria: 1. Men and women aged between 18 and 65 (inclusive) at the time of Screening visit. 2. Participants with Body Mass Index (BMI) of ≥18.5 and ≤32.0 kg/m2 and weight of at least 50 kg at Screening. 3. Non-smokers or former smokers who have smoked ≤ 100 cigarettes in their lifetime and have not consumed any tobacco or tobacco-containing products for at least 3 months prior to Screening. 4. Females must not be pregnant or lactating and must use acceptable, highly effective double contraception from Screening until 3 months after the last dose of the Investigational product. Key Exclusion Criteria: 1. Participants with contraindications or sensitivity to any components of the study treatment. 2. Participants with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders. 3. Participants with histories or active conditions of asthma, sleep apnea, chronic obstructive pulmonary disease (COPD), pu