A Phase Ia Clinical Trial of HW241045

March 3, 2026 updated by: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Hongyun Wang, Doctor
          • Phone Number: +86 18611513192
          • Email: wanghy@pumch.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HW241045
Single oral dose of HW241045
Drug: HW241045
Dose 1 to Dose 7
Placebo Comparator: Placebo
Single oral dose of Placebo
Drug: Placebo
Dose 1 to Dose 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RFIP-Ia-202507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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