A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of HS-20118 in Adult Participants
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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 .
Description
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 1 will consist of 5 cohorts, i.e., X1 mg, X2 mg, X3 mg, X4 mg, and X5 mg dose cohorts (each cohort will include 3 participants to receive placebo). There will be no restriction on the male-to-female ratio. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 60 participants. Partici…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 of 18-28 kg/m2 (inclusive); 3. Normal results or abnormal results but without clinical significance in comprehensive examinations, including general physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal color Doppler ultrasound, and chest X-ray from the frontal and lateral posi…
Interventions
- DrugHS-20118
Single and multiple ascending doses of HS-20118 orally
- OtherHS-20118 placebo
Single and multiple ascending doses of HS-20118-matched placebo orally
Locations (9)
- Kinetic Clinical ResearchAnaheim, California
- Clinitiative - Floridian Clinical Research, LLCMiami Lakes, Florida
- NuLine Clinical Trial Center (Network)Pompano Beach, Florida
- Pacific Clinical Research Network (PCRN), AucklandTakapuna, Auckland
- Pacific Clinical Research Network (PCRN), ChristchurchChristchurch, Christchurch
- Momentum Clinical Research, DunedinDunedin, Dunedin