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NCT Number: NCT07737496

A Study of HW243040 in Healthy Participants

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.

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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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HW243040

Drug

HW243040 will be administered orally under fasting or fed conditions.

Placebo

Drug

Placebo will be administered orally under fasting or fed conditions.

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: Up to day 11

Secondary outcomes

  1. Maximum Concentration (Cmax) of HW243040

    Time frame: Up to day 11

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

    Time frame: Up to day 11

  3. Time for Cmax (Tmax) of HW243040

    Time frame: Up to day 11

  4. Half-life of HW243040

    Time frame: Up to day 11

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Single-Center, Dose-Escalation, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW243040 in Healthy Participants

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 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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