Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118
Recruiting
Phase 1
Interventional Study
Psoriasis
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 142 (estimated)
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
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About This Trial
The study will be conducted in 2 parts (SAD and FE for Part 1 and MAD for Part2).
Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 and explore the food effect and fasting time on PK after a single oral dose in healthy participants.
Part 2 is a multi-center, randomized, double-blind, placebo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
For the SAD study:
1. Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg; body mass index (weight/square of height (kg/m2)) within the range …
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