A Study of HW243040 in Healthy Participants

NCT07737496 | Not Yet Recruiting Phase 1

• 1 other identifier: HW243040-101
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events

  Up to day 11

Secondary Outcomes (4)

• Maximum Concentration (Cmax) of HW243040

  Up to day 11

• Area Under the Concentration Versus Time Curve (AUC) of HW243040

  Up to day 11

• Time for Cmax (Tmax) of HW243040

  Up to day 11

• Half-life of HW243040

  Up to day 11

Study Arms (2)

HW243040 group

EXPERIMENTAL

Drug: HW243040

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HW243040 DRUG

HW243040 will be administered orally under fasting or fed conditions.

HW243040 group

Placebo DRUG

Placebo will be administered orally under fasting or fed conditions.

Placebo group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent must be obtained/signed prior to trial participation.
• Aged between 18 and 55 years old, both healthy males and females are eligible.
• Female participates must have a body weight of ≥ 45 kg and male participates ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m\^2.

You may not qualify if:

• History or presence of any clinically severe disorders of urinary, cardiovascular, endocrine, nervous, gastrointestinal, respiratory, hematologic, immune systems, psychiatric illnesses or metabolic abnormalities; or other conditions judged by the Investigator to confound trial outcomes, e.g., intestinal diseases (irritable bowel syndrome), urinary tract infections.
• History of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps).
• Any conditions or diseases that, in the Investigator's judgment, may affect the absorption, metabolism and/or excretion of the investigational product.
• History of drug abuse or dependence.
• Hypersensitivity to any ingredient of the study drug，or history of allergic disorders or allergic diathesis.
• Any other condition that, in the opinion of the investigator, renders the participant unsuitable to participate in the study.

Sponsors & Collaborators

• Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Central Study Contacts

Lifei Liu

CONTACT

86-027-87173753; liulifei@renfu.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CN (1)