Actively Recruiting
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
Led by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company · Updated on 2026-01-28
104
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (how the drug moves through the body), pharmacodynamics (how the drug affects the body), and the effect of food on HW201877 in healthy adult volunteers aged 18 to 55 years. This study compares HW201877 with a placebo to better understand how the drug behaves and its safety profile in people without inflammatory bowel disease or other health issues. Participants receive either single or multiple oral doses of HW201877 capsules or matching placebo capsules. The study includes a single ascending dose part with a two-period crossover to assess the food effect, followed by a multiple ascending dose part. Each dosing period tests increasing amounts of the drug or placebo to monitor effects and tolerability. During the trial, participants will be closely monitored from Day 1 to Day 5 for any treatment-emergent adverse events and their severity. Assessments include clinical evaluations and laboratory tests to ensure participant safety. The study lasts for a few days of dosing and observation, with participants fully informed and consenting before joining. The sponsor is Wuhan Humanwell Innovative Drug Research and Development Center Limited Company.
CONDITIONS
Brief Title
A Phase I Study of HW201877 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent after understanding study details and potential risks
- Willing to use effective contraceptives from screening until 6 months after last dose
- Aged 18 to 55 years, male or female
- Male subjects weigh at least 50 kg; female subjects weigh at least 45 kg
- Body mass index between 18 and 28 kg/m2 inclusive
You will not qualify if you...
- Smoking more than 5 cigarettes per day within 3 months before screening
- History of allergies to multiple drugs or foods
- History of drug abuse or alcoholism (consuming more than 14 alcohol units per week)
- Use of medications that affect liver enzyme activity within 28 days before screening
- Consumption of special diets or strenuous exercise within 2 weeks before screening
- Participation in other clinical trials or use of investigational drugs within 3 months before first dose
- Clinically significant abnormalities or history of serious diseases within 12 months before screening
- Unable to tolerate venipuncture or history of needle phobia
- Deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive single or multiple oral doses of HW201877 capsules or placebo to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics.
Daily visits during dosing period
Duration - Up to 4 weeks
Participants are monitored for treatment emergent adverse events after dosing is completed.
1 to 2 visits after dosing
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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