HS-20118 for Psoriasis
This study is testing a new oral medication called HS-20118 for people with psoriasis. It aims to understand how safe HS-20118 is, how well your body handles it, and how it affects psoriasis. The study will involve giving participants either HS-20118 or a placebo (a pill with no medicine) in different doses. Part 1 includes healthy adults aged 18-45, while Part 2 focuses on patients with moderate to severe plaque psoriasis. The main goal is to track any side effects or health changes. The study plans to enroll 132 participants, but its current recruitment status is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled study with two parts, involving a total of 132 participants. It will test single and multiple doses of HS-20118.
- What's involved
- Participants will take HS-20118 or a placebo orally. They will have blood samples taken and safety examinations during the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored from Day 1 up to Day 36 for single doses, and from Day 1 up to Day 71 for multiple doses.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
At a glance
Conditions
Where it's being run
9 sites across 8 statesWho to contact
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What this trial measures
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuationDay 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
- Number of participants with abnormalities of physical examinationDay 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Physical examination includes skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, and spine/limbs, etc.
- Number of participants with abnormalities of vital signsDay 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Vital sign measured include body temperature, blood pressure, pulse, and respiratory rate.
- Number of participants with clinical laboratory abnormalitiesDay 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Clinical laboratory tests include blood biochemistry test, hematology test, urinalysis, coagulation function test, etc.
- Number of participants with abnormalities of electrocardiogram (ECG) parametersDay 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.