Actively Recruiting
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of YP05002 in Healthy Adults
Led by Yaopharma Co., Ltd. · Updated on 2025-08-06
76
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating YP05002 Tablets in healthy adults aged 18 to 65 years to study its safety, tolerability, how the body processes the drug, potential effects on the body, and how food may influence the drug. This phase I trial is randomized, double-blind, and placebo-controlled, involving single and multiple ascending doses to assess these factors carefully. Participants will be assigned to one of several groups receiving different doses of YP05002 or a matching placebo once daily as tablets. The study includes single ascending dose (SAD) cohorts and multiple ascending dose (MAD) cohorts, where safety and drug behavior are observed up to day 14 for SAD and up to day 41 for MAD. Each dose group will be monitored closely throughout these periods. During the trial, participants will attend scheduled visits for treatments, laboratory tests, physical exams, ECGs, vital signs checks, and other assessments to monitor health and collect data. Researchers will track any adverse events and serious adverse events in each dose group. The primary outcome is safety during the observation periods, while secondary outcomes include measuring the highest concentration of the drug in the blood. The total participation period varies by dosing schedule.
CONDITIONS
Brief Title
A Study of YP05002 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy male and female participants aged 18-65 years (both inclusive) with no race restrictions.
- In good health as determined by the Investigator, with no clinically significant findings from medical or psychiatric history, physical examination, ECG, vital signs, and clinical labs.
You will not qualify if you...
- Evidence of any clinically significant active or chronic disease.
- History of using drugs affecting absorption, distribution, metabolism, or excretion within 14 days or 5 half-lives prior to first dose.
- Gastrointestinal disorders with impaired gastric emptying or prolonged use of medications modulating gastrointestinal motility.
- Clinically relevant acute or chronic medical conditions posing safety risks or interfering with study assessments.
- Any malignancy (except basal cell carcinoma and squamous cell carcinoma of the skin) in the previous 5 years.
- Diagnosis of any type of pancreatitis.
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.
screening and enrollment visit
Duration - Up to 41 days depending on cohort assignment
Participants receive study drug or placebo once daily as part of dose cohorts to evaluate safety and pharmacokinetics.
Multiple visits depending on cohort assignment
Trial Site Locations
Total: 1 location
1
Nucleus Network Melbourne Clinic
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
Y
Yalei Xie
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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