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Recruiting Phase 1 NCT07448194

A Phase Ia Clinical Trial of HW241045

Trial Parameters

Condition Healthy Volunteers
Sponsor Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 56
Sex ALL
Min Age 18 Years
Max Age 55 Years
Start Date 2025-11-24
Completion 2026-06
Interventions
HW241045Placebo

Brief Summary

This is a Phase Ia, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetic (PK) of HW241045 in healthy subjects following a single ascending dose.

Eligibility Criteria

Key Inclusion Criteria: * The subjects have been fully informed of the trial's purpose, nature, methodology, and potential adverse reactions. They voluntarily participate in the trial and sign the informed consent form prior to the initiation of any study procedures; * Healthy male and female subjects aged 18 to 55 years; * Female subjects must have a body weight of ≥ 45 kg and male subjects ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m². Key Exclusion Criteria: * Subjects with a history of or current severe clinical disease involving any of the following systems: circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, mental, or metabolic systems; or subjects with any other disease that the investigator judges may interfere with the study results; * Subjects with a history of severe trauma or major surgery within 3 months prior to screening; or subjects planning to undergo surgery during the trial period or within two weeks after study comple

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