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.
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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

xiaohualuck@sina.com

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