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NOT YET RECRUITING
NCT07892469
PHASE1

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This is a first-in-human study of NH302 injection in healthy participants. The study will test single intravenous doses of NH302 to evaluate its safety and tolerability, how the body processes NH302, and its effects on selected pharmacodynamic markers. Approximately 62 healthy adults will participate. Participants will receive one dose of NH302 or placebo. The study includes screening, baseline, treatment, and follow-up.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Administration of NH302 Injection in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2026-09-30

Completion Date

2027-09-30

Last Updated

2026-10-23

Healthy Volunteers

Yes

Interventions

DRUG

NH302 injection

NH302 is a selective peripheral kappa opioid receptor agonist. It is supplied as a sterile injection (1 mL: 0.1 mg). For each dose group, NH302 is diluted with 0.9% sodium chloride injection to a total volume of 20 mL and administered as a single intravenous infusion over 15 minutes ± 10 seconds on Day 1. Dose levels: 0.15, 0.45, 1, 2, 3.5, and 5 μg/kg. The dose is calculated based on body weight on Day 1.

DRUG

Placebo

Matching placebo supplied by the sponsor (1 mL: 0 mg). It has the same appearance as NH302 injection and is prepared and administered in the same manner to maintain blinding: total volume 20 mL, single intravenous infusion over 15 minutes ± 10 seconds on Day 1.