Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects

• Status: Recruiting
• Trial end date: 2023-04-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, and pharmacokinetics of ASC11 plus ritonavir tablets in healthy subjects and an open-label, cross-over study evaluating the effect of food on the pharmacokinetics of ASC11 plus ritonavir tablets

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

Criteria

Inclusion Criteria:

• Healthy male or female subjects aged 18-60 years (including boundary values)

• If a woman has no planned pregnancy within 6 months after signing the informed consent, and is willing to use effective contraception (e.g. condom, uterine cap, non-hormonal intrauterine device [IUD]) for at least 3 months from the first administration of the study intervention to the last administration of the study intervention; Or not fertile (e.g. surgical sterilization [bilateral oophorectomy, tubal ligation, or hysterectomy] or natural sterilization [continuous > 12 months without menstruation])

• If male, agree to use effective contraception throughout the study intervention and for at least 3 months after the last dose of the study intervention, and do not donate sperm.

• General good health based on history, physical examination (screening and check-in assessment), vital signs and other screening assessments.

• Able to understand the research content, comply with the research protocol, and voluntarily sign the informed consent.

Exclusion Criteria:

• Pregnant and lactating women.

• Patients with acute or chronic diseases, including but not limited to cardiovascular, digestive, respiratory, urinary, nervous, endocrine, immune, musculoskeletal, and skin conditions, were judged by the investigator.

• Any previous or existing hematological disorders or disorders, major liver disease, family history of bleeding/platelet disease.

• Previous or existing cancer (other than basal cell carcinoma or squamous cell carcinoma of the skin), or hygrosis.

• Have an autoimmune disease, immunosuppression, or any form of immune deficiency.