Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
Condition(s) studied
Investigational drug(s) / intervention(s)
HS-20118: Single and multiple ascending doses of HS-20118 orally
HS-20118 placebo: Single and multiple ascending doses of HS-20118-matched placebo orally
Study summary
The study will be conducted in 2 parts (SAD 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 after a single oral dose in healthy participants.
Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis .
Eligibility
Primary outcome measure(s)
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation — Day 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 examination — Day 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 signs — Day 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 abnormalities — Day 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) parameters — Day 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.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Kinetic Clinical Research | Anaheim | California | Not Yet Recruiting |
| Clinitiative - Floridian Clinical Research, LLC | Miami Lakes | Florida | Not Yet Recruiting |
| NuLine Clinical Trial Center (Network) | Pompano Beach | Florida | Not Yet Recruiting |
| Pacific Clinical Research Network (PCRN), Auckland | Takapuna | Auckland | Recruiting |
| Pacific Clinical Research Network (PCRN), Christchurch | Christchurch | Christchurch | Not Yet Recruiting |
| Momentum Clinical Research, Dunedin | Dunedin | Dunedin | Not Yet Recruiting |
| Momentum Clinical Research, Pukekohe | Pukekohe | Pukekohe | Not Yet Recruiting |
| Pacific Clinical Research Network (PCRN), Wellington | Upper Hutt | Upper Hutt | Not Yet Recruiting |
| Momentum Clinical Research, Wellington | Mount Cook | Wellington Region | Not Yet Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06846710 on ClinicalTrials.gov ↗ ← All trials in the USA