Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect 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 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-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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

HS-20118
Drug
HS-20118

Treatment groups

142 Participants

are divided into 2 treatment groups

Group A: HS-20118Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence, sever ity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation

adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation

Time frame