Actively Recruiting
A Phase I Study of HW201877 in Healthy Subjects
Led by Wuhan Humanwell Innovative Drug Research and Development Center Limited Company · Updated on 2026-01-28
104
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).
CONDITIONS
Official Title
A Phase I Study of HW201877 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and fully understood study procedures and risks
- Willing to use effective contraception from screening to at least 6 months after last dose
- Age between 18 and 55 years inclusive, male or female
- Male subjects weighing at least 50 kg and female subjects weighing at least 45 kg
- Body mass index (BMI) between 18 and 28 kg/m2 inclusive
You will not qualify if you...
- Smoking more than 5 cigarettes per day within 3 months prior to screening
- History of allergies to multiple drugs and foods
- History of drug abuse or alcoholism (consuming 14 or more units of alcohol per week)
- Use of medications altering liver enzyme activity within 28 days prior to screening
- Consumption of special diets or strenuous exercise within 2 weeks prior to screening
- Participation in other clinical drug trials or use of investigational drugs within 3 months prior to study drug administration
- Clinically significant abnormalities in laboratory tests or history of major diseases within 12 months prior to screening
- Unable to tolerate venipuncture or history of needle or blood phobia
- Deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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