Actively Recruiting
A Phase I Clinical Trial to Evaluate the Single Dose Ascending and Food Effects of PG-033 in Healthy Adults
Led by Prime Gene Therapeutics Co., Ltd. · Updated on 2025-06-10
52
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles of single ascending oral doses(SAD) of PG-033 by directly comparing it with placebo. Meanwhile, the impact of a high-fat meal on the pharmacokinetics of PG-033 will also be evaluated. The research will also explore the potential metabolites and metabolic pathways of PG-033 within the human body，as well as investigate the effect of PG-033 on the QTc interval.
CONDITIONS
Official Title
A Phase I Clinical Trial to Evaluate the Single Dose Ascending and Food Effects of PG-033 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Read, understood, and signed informed consent before any study procedures.
- Male or female aged 18 to 45 years.
- Body weight at least 50.0 kg for males, or at least 45.0 kg for females.
- Body mass index (BMI) between 19.0 and 26.0 kg/m².
- Normal results in vital signs, physical exams, lab tests, chest X-ray, and adrenal ultrasound, or any abnormalities deemed not clinically significant.
- Willing to avoid pregnancy or use effective contraception from consent signing to three months after last dose.
- Able to communicate well with investigators and follow study requirements.
You will not qualify if you...
- Abnormal electrocardiogram findings such as QT/QTcF > 440 ms, PR interval > 200 ms, or QRS duration > 100 ms.
- Allergy to PG-033 or related substances, or having multiple drug or food allergies.
- History of chronic or severe diseases affecting circulatory, urinary, respiratory, hematological, endocrine, immune, mental, neurological, or digestive systems.
- Major surgery within 6 months before dosing, planned surgery during study, or surgery affecting drug safety evaluation.
- Use of any drugs or health products within 2 weeks before dosing.
- Use of drugs affecting liver metabolism within 4 weeks before dosing.
- Unable to avoid caffeine, alcohol, or certain foods from 48 hours before dosing until study end.
- Received live attenuated vaccine within 4 weeks before dosing or planned during study.
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV.
- Participation in another clinical trial within 3 months before dosing.
- Blood donation or loss of ≥400 mL blood within 3 months before dosing, or planned donation during or 1 month after study.
- Consumed more than 2 units of alcohol daily within 30 days before screening or unable to abstain during study.
- Smoked more than 5 cigarettes daily within 3 months before screening or unable to stop during study.
- History of drug abuse within 1 year or positive drug abuse test.
- Unable to tolerate intravenous puncture or history of fainting at sight of needles or blood.
- Special dietary needs incompatible with study diet.
- Pregnant or breastfeeding women.
- Any other condition judged unsuitable by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Shijitan Hospital , Capital Medical University
Beijing, Beijing Municipality, China, 100038
Actively Recruiting
Research Team
X
Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer
CONTACT
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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