Health TrialsbyHealthPanel

A PhaseⅠ Study of HW252001 in Healthy Subjects

ConditionIPF
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHubei Bio-Pharmaceutical Industrial Technological Institute Inc.

About this trial

This is a phase 1, randomized, double-blind, placebo-controlled, Single/multiple ascending doses (SAD/MAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The participant must sign informed consent prior to the trial, understand the trial's content, procedures, and potential adverse reactions, and be able to complete the study in accordance with the trial protocol requirements.

Healthy male or female subjects, aged ≥18 and ≤55 years on the day of signing the informed consent form.

During the screening period, male participants must weigh ≥50 kg, and female participants must weigh ≥45 kg. Body Mass Index (BMI) = weight (kg) / height² (m²), and must be within the range of 19 kg/m² to 26 kg/m².

Disqualifiers

Subjects with a 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);

Subjects judged by the investigator to have any condition or disorder that may affect the absorption, metabolism, and/or excretion of the study drug.

Subjects with severe infection, severe trauma, or major surgery within 3 months prior to the screening or baseline period; or those with planned surgery during the trial period.

Subjects with a history of blood donation or significant blood loss (≥400 mL) within 8 weeks prior to the screening or baseline period, or those who have received a blood transfusion within 4 weeks prior to the screening or baseline period; or those who intend to donate blood during the trial period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HW252001

    Drug

    HW252001 will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).

  • Placebo

    Drug

    Placebo will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: HW252001Experimental 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 HW252001

Time frame
up to 11 days

Secondary outcomes

1

Cmax

PK Paramete

Time frame
up to 11 days
2

Tmax

PK Paramete

Time frame
up to 11 days

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

This trial is not recruiting at the moment. You can still explore other options: