A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AH-008 Following Single Ascending Dose Administration in Healthy Subjects
AnHorn Medicines Co. Ltd.
Summary
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, parallel-group, single ascending dose (SAD) study to evaluate the safety, tolerability, and pharmacokinetics of AH-008 administered as a single intravenous infusion in healthy adult subjects. Four sequential dose cohorts will be evaluated, each with sentinel dosing and SRC-reviewed dose escalation.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Age range: 18 to 65 years. 2. Body Mass Index (BMI) between 19 and 32 kg/m² (inclusive). Males: Body weight ≥ 50 kg; Females: Body weight ≥ 40 kg 3. Subjects understand and agree to comply with planned study procedures, can communicate well with the Investigator, understand the requirements of the study, and have provided written informed consent. 4. Subject is considered healthy, in the opinion of the Investigator, based on a detailed medical history, complete physical examination, vital signs, 12-lead ECG, and safety laboratory tests evaluation. 5. Female of non-child…
Interventions
- DrugAH-008 for Injection, 150 mg
Lyophilized powder
- DrugAH-008 for Injection, Placebo
Lyophilized powder
Location
- ICON Clinial Research UnitSalt Lake City, Utah