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

Conditions

• Chemotherapy-induced Peripheral Neuropathy (CIPN)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• AH-008 for Injection, 150 mg — DRUG
  Lyophilized powder
• AH-008 for Injection, Placebo — DRUG
  Lyophilized powder

Study Details

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.

Key Dates

First listed

Jul 13, 2026

Start date

Jun 10, 2026

Status verified

Jul 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Experimental: AH-008
  Single IV infusion at escalating doses across 4 sequential cohorts
• Placebo Comparator: Matching placebo
  Matching placebo IV infusion with no active ingredient

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From Baseline (Day -1) through Day 3 (48 hours after dosing) ]

Locations (1)

Find similar trials in Salt Lake City, UT

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