Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects

Recruiting Phase 1 Interventional Study
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
32 (estimated)
Sponsor
AnHorn Medicines Co. Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility 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 t…
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