GenSci144 Tablets Phase I Clinical Trial
Recruiting
Phase 1
Interventional Study
Phenylketonuria
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
- Other
- Participants needed
- 48 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
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About This Trial
This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels. It was conducted using a randomized, double-blind, placebo-controlled design, primarily to evaluate the drug's safety and tolerability, while also exploring its pharmacokinetic and pharmacodynamic characteristics in the body, p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Healthy men and women aged 18 to 45, with at least 3 people of the same gender in each group.
* BMI 19\~26 kg/m², men weigh ≥50 kg, women ≥45 kg.
* Voluntarily sign the informed consent form, fully aware of the research risks and procedures.
* Use reliable contraception for 3 …
Contacts