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

NCT07697560 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy (CIPN)

Interventions

DRUG

AH-008 for Injection, 150 mg

Lyophilized powder

DRUG

AH-008 for Injection, Placebo

Lyophilized powder

Sponsors & Collaborators

  • AnHorn Medicines Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07697560 on ClinicalTrials.gov