Phase 1 testing of HW201877 in healthy adults

A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect of HW201877 in Healthy Volunteers.

This test will try HW201877 in healthy adults to see if it is safe, how well people tolerate it, and how their bodies process the drug.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Wuhan Humanwell Innovative Drug Research and Development Center Limited Company (Industry-sponsored)
• Locations: 1 site (Changchun)
• Trial ID: NCT07373457 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 1 trial enrolls healthy adults to examine safety, tolerability, pharmacokinetics, pharmacodynamics, and the effect of food on HW201877. Part 1 uses single ascending doses and includes a two-period crossover cohort to measure food effect, while Part 2 uses multiple ascending doses to study repeat dosing. Subjects are randomized to HW201877 capsules or placebo and monitored with clinical labs, adverse event reporting, and serial PK/PD sampling. The trial is conducted at The First Hospital of Jilin University in Changchun, China with participants aged 18–55 and prespecified weight, BMI, and smoking criteria.

Who should consider this trial

Good fit: Ideal participants are healthy men and women aged 18–55 with BMI 18–28 kg/m2 who meet the minimum weight requirements, are willing to use effective contraception, and can attend the Changchun site.

Not a fit: People with active IBD or other significant medical conditions, recent heavy smoking or substance use, recent use of drugs that alter liver enzymes, or those outside the age/BMI ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify safe dosing and PK/PD data needed to advance HW201877 into patient trials for IBD and other conditions.

How similar studies have performed: Single- and multiple-ascending-dose, randomized, placebo-controlled Phase 1 designs are common and have successfully provided safety and PK data for many IBD drug candidates, though HW201877 itself appears novel and untested in patients.

Eligibility criteria

Key Inclusion Criteria:

* Before enrollment in the study, each subject shall sign the informed consent form and be fully apprised of the study content, implementation procedures and potential adverse reactions.
* Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 6 months after the last dose administration.
* 18 years to 55 years (inclusive), male and female.
* Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-28 kg/m2 (inclusive) .

Key Exclusion Criteria:

* Smoking more than 5 cigarettes per day within 3 months prior to screening.
* Allergic diathesis (with a history of allergies to multiple drugs and foods).
* A history of drug abuse and/or alcoholism (consuming 14 units of alcohol per week; 1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine).
* Have taken any medications that alter hepatic enzyme activity within 28 days prior to screening.
* Have consumed special diets (including pitaya, mango, lime, grapefruit, carambola, orange, grapefruit or grapefruit-containing products, etc.) or engaged in strenuous exercise within 2 weeks prior to screening, or having other factors that may affect the absorption, distribution, metabolism and excretion of the study drug.
* Have taken any investigational drugs or participated in any other clinical drug trials within 3 months prior to the first administration of the study drug.
* Clinically significant abnormalities in clinical laboratory tests, or a history of clinically significant findings of the following diseases within 12 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardio-cerebrovascular diseases).
* Unable to tolerate venipuncture, or with a history of needle phobia or hematophobia.
* Not suitable for this study as judged by the investigator.

Where this trial is running

Changchun

• The First Hospital of Jilin University — Changchun, China (Recruiting)

Conditions Healthy Participants; IBD