Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT07896915

A Study to Evaluate the Pharmacokinetic Characteristics of HS-20118 Under Different Dosing Conditions in Healthy Participants

Conditions: Healthy Participants

Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 32
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Location: Haikou People's Hospital Haikou Hainan

Summary

This study is a single-center, open-label, randomized, four-period dosing clinical study designed to evaluate the pharmacokinetic characteristics of HS-20118 under different dosing conditions in healthy participants. It is planned to enroll 32 healthy participants.

Eligibility Criteria

Inclusion Criteria: 1. Participants fully understand the purpose, nature, methods, and potential adverse events of the study, participate voluntarily, and have signed the written informed consent form. 2. Adult male and female participants aged 18 to 45 years (inclusive), on the date of signing the informed consent form. 3. Body weight ≥ 50.0 kg for male participants, ≥ 45.0 kg for female participants, and ≤ 100.0 kg for both; body mass index (BMI) within the range of 18.0 to 26.0 kg/m2, inclusive. 4. Agrees to have no procreative plans or plans for sperm/oocyte donation during the study and for 6 months after the last dose of study drug, and voluntarily agrees to use highly effective methods of contraception. Exclusion Criteria: 1. Clinically significant abnormalities in physical examination, vital signs, clinical laboratory tests, 12-lead electrocardiogram (ECG), abdominal color Doppler ultrasound, chest X-ray, or CT scan during the screening period. 2. Past history of, or current, serious diseases involving the neurological, psychiatric, gastrointestinal (digestive), cardiovascular (circulatory), respiratory, or urinary systems, or any new-onset illness prior to the administration of the investigational product, which, in the opinion of the investigator, makes the participant unsuitable for participation in the study. 3. Active infection (including chronic or localized infection) within 7 days prior to screening, history of recurrent infections with underlying diseases predisposing to infection, or history of opportunistic infections. 4. Use of any prescription drugs, over-the-counter (OTC) drugs, herbal medicines, or health supplements (excluding topical preparations exerting localized effects) within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to the first dose. 5. Receipt of any vaccine within 4 weeks prior to the first dose, or plan to receive any vaccine during the study.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07896915). StuddyBuddy aggregates publicly available trial information.