Actively Recruiting
A Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Food Effects of PG-033 in Healthy Adults
Led by Prime Gene Therapeutics Co., Ltd. · Updated on 2026-06-02
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of single ascending oral doses of PG-033 in healthy adults aged 18 to 45 years. The study also examines how a high-fat meal affects the pharmacokinetics of PG-033, explores its potential metabolites and metabolic pathways, and investigates its impact on the QTc interval. This is a phase I clinical trial conducted by Prime Gene Therapeutics Co., Ltd. The study includes two parts: a single ascending dose (SAD) study and a food effect (FE) study. In the SAD study, about 40 participants are randomized in a 3:1 ratio to receive either PG-033 or a placebo across five dose levels, increasing from low to high. The FE study is a two-period, two-sequence crossover design involving 12 participants divided into two groups, who receive PG-033 either on an empty stomach or after a high-fat meal, with a 7-day washout period between doses. Participants will undergo safety and tolerability assessments for up to 7 days in the SAD study and 14 days in the FE study. Researchers will measure pharmacokinetic parameters such as Cmax, Tmax, AUC, half-life, volume of distribution, clearance, and mean residence time within 3 days post-dose. The QT interval will be monitored up to 24 hours after dosing. Screening includes vital signs, laboratory tests, chest X-ray, and ultrasound to confirm health status. Participants will be monitored closely for any adverse effects throughout the study.
CONDITIONS
Brief 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
- Male body weight at least 50.0 kg; female body weight at least 45.0 kg
- Body mass index (BMI) between 19.0 and 26.0 kg/m²
- Normal vital signs, physical exam, lab tests, chest X-ray, and adrenal ultrasound or judged clinically insignificant abnormalities
- Willing to avoid pregnancy or use effective contraception from consent to three months after last dose
- Able to communicate and comply with study requirements
You will not qualify if you...
- Abnormal electrocardiogram results during screening (e.g., QT/QTcF > 440 ms, PR interval > 200 ms, QRS duration > 100 ms, significant P wave or ST-T changes)
- Known allergy to PG-033 or related substances, or allergic constitution
- History of chronic or severe diseases in circulatory, urinary, respiratory, hematological, endocrine, immune, mental, neurological, or digestive systems
- Major surgery within 6 months before dosing or planned surgery during study
- 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
- Recent live attenuated vaccine within 4 weeks before dosing or planned during study
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV during screening
- Participation in other clinical trials within 3 months before dosing
- Blood donation or loss ≥400 mL within 3 months before dosing, or planned during or soon after study
- High alcohol consumption or inability to abstain during study
- Smoking more than 5 cigarettes per day or unable to stop during study
- History or positive screening for drug abuse within 1 year
- Intolerance to needles or history of fainting at blood sight
- Special dietary needs incompatible with study diet
- Pregnant or breastfeeding women
- Other conditions judged unsuitable by 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 14 days
Participants receive a single dose of PG-033 or placebo in dose-escalation groups or participate in a food effect crossover study involving single doses with a washout period.
1 dosing visit and up to 3 follow-up visits for pharmacokinetic assessments
Duration - 7 to 14 days depending on study part
Participants are monitored for safety and tolerability after dosing.
Up to 4 visits for safety and tolerability checks
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
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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