A Phase Ia Clinical Trial of HW241045
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHubei Bio-Pharmaceutical Industrial Technological Institute Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
HW241045
DrugDose 1 to Dose 7
Placebo
DrugDose 1 to Dose 7
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: HW241045Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of single oral dose of HW241045 in healthy adult volunteers
Time frame
Up to 48 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov