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

Detailed criteria

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

Drug
AH-008 for Injection, 150 mg
Lyophilized powder
Drug
AH-008 for Injection, Placebo
Lyophilized powder

Location

ICON Clinial Research Unit
Salt Lake City, Utah
yrwee@anhornmed.com +886 2 2786 2568

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

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