Health TrialsbyHealthPanel

A Study of HW243040 in Healthy Participants

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHubei Bio-Pharmaceutical Industrial Technological Institute Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m².

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HW243040

    Drug

    HW243040 will be administered orally as a tablet.

  • Placebo

    Drug

    Placebo will be administered orally as a tablet.

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: HW243040 groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Lead sponsor

Source ClinicalTrials.gov
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