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NCT Number: NCT07448194

A Phase Ia Clinical Trial of HW241045

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

Location status: Recruiting

Location contact

Hongyun Wang, Doctor

CONTACT

[email protected]

+86 18611513192

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 completion;
  • Subjects with a history of gastrointestinal, hepatic, or renal diseases that affect drug absorption or metabolism; or those with conditions known or suspected to interfere with drug ingestion, transport, absorption, distribution, metabolism, or excretion;
  • Subjects with clinically significant abnormalities in any screening test results as judged by the investigator;
  • Subjects with a history of drug or food allergy, allergic disorders, or atopic diathesis; or those with confirmed hypersensitivity to any component of the investigational drug;
  • Subjects with difficult venous blood collection, or whose physical condition cannot tolerate intensive blood sampling;
  • Not suitable for this study as judged by the investigator.

Treatment and study plan

HW241045

Drug

Dose 1 to Dose 7

Placebo

Drug

Dose 1 to Dose 7

Primary outcomes

  1. The number and severity of treatment emergent adverse events (TEAEs)

    Time frame: Up to 48 hours

    To assess the safety and tolerability of single oral dose of HW241045 in healthy adult volunteers

Sponsors and collaborators

Lead sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Industry

Registry information

Official study title

A Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of HW241045 Tablets Following a Single Dose in Healthy Subjects: A Single-center, Randomized, Double-blind, Placebo-controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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