Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
ConditionPsoriasis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
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);
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 position ;
Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;
Disqualifiers
Participants with immune-related diseases and medical history at screening;
Participants with a history of drug or other allergies who are considered by the investigator to be at high risk for participating in this study, or who may be allergic to the investigational medicinal product or any component of the investigational medicinal product as judged by the investigator;
History of drug abuse within the past 5 years or use of illicit drugs within 3 months before the study; or positive for urine drug screening;
Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
Trial design
Treatments tested in this trial
- HS-20118
- HS-20118 placebo
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov