A Phase I Clinical Trial to Evaluate the Single Dose Ascending and Food Effects of PG-033 in Healthy Adults
Recruiting
Phase 1
Interventional Study
Lichen Simplex Chronicus
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 45
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 52 (estimated)
- Sponsor
- Prime Gene Therapeutics Co., Ltd. · Industry
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About This Trial
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 wel…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 1\. Read, understood, and signed an ICF before any investigational procedure(s) are performed.
2.Male or female aged 18 to 45 (including threshold). 3. For male subjects, the body weight should be ≥ 50.0 kg, and for female subjects, the body weight should be ≥ 45.0 kg. The …
Contacts
Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer
+86 13466590802
CONTACT