Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects
Study Details
Study Description
Brief 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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ASC11 tablets Part 1: Subjects will receive ASC11 tablets on single ascending doses with proposed dose levels of ASC11 tablets: 100mg (cohort 1), 200 mg (cohort 2), 400mg (cohort 3) and 800 mg (cohort 4). Part 2: Subjects will receive ASC11tablets 100 to 300 mg (including 3 cohorts) and ASC11 tablets 300 mg(cohort 4) twice daily (BID) for 5 consecutive days and receive a single dose in the early morning of Day 6. Part 3: Subjects will be randomized to receive ASC11 tablets two single 200 mg or 300 mg doses (fed or fasted) |
Drug: ASC11 tablets
Part 1: Subjects will receive ASC11 tablets on single ascending doses with proposed dose levels of ASC11 tablets: 100mg (cohort 1), 200 mg (cohort 2), 400mg (cohort 3) and 800 mg (cohort 4).
Part 2: Subjects will receive ASC11tablets 100 to 300 mg (including 3 cohorts) and ASC11 tablets 300 mg(cohort 4) twice daily (BID) for 5 consecutive days and receive a single dose in the early morning of Day 6.
Part 3: Subjects will be randomized to receive ASC11 tablets two single 200 mg or 300 mg doses (fed or fasted)
|
| Experimental: RTV tablets Part 1: Subjects will receive RTV tablets on 100 mg (cohort 1-4). Part 2: Subjects will receive RTV tablets 100 mg (including 3 cohorts) twice daily (BID) for 5 consecutive days and receive a single dose in the early morning of Day 6. Part 3: Subjects will be randomized to receive two single 100 mg doses (fed or fasted) |
Drug: RTV tablets
Part 1: Subjects will receive RTV tablets on 100 mg (cohort 1-4). Part 2: Subjects will receive RTV tablets 100 mg (including 3 cohorts) twice daily (BID) for 5 consecutive days and receive a single dose in the early morning of Day 6.
Part 3: Subjects will be randomized to receive two single 100 mg doses (fed or fasted)
|
| Placebo Comparator: Placebo Part 1 and 2: Subjects will be randomized to receive placebo |
Drug: Placebo
Part 1 and 2: Subjects will be randomized to receive placebo.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) of ASC11 relative to placebo [From screening through study completion, up to 14 days]
To evaluate the safety and tolerability of ASC11 tablets combined with Ritonavir tablets in healthy subjects given single and multiple dose increments.
Secondary Outcome Measures
- Title Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-inf [From screening through study completion, up to 14 days]
Area under the concentration-time curve from the time of dosing extrapolated to time infinity
- Title -Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Cmax [From screening through study completion, up to 14 days]
Maximum concentration
- Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Tmax [From screening through study completion, up to 14 days]
Time to Maximum Observed Plasma Concentration
- Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-t [From screening through study completion, up to 14 days]
Area under the concentration-time curve from the time of dosing to the last measurable concentration
- Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: T1/2 [From screening through study completion, up to 14 days]
Elimination half-life
- Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: CL/F [From screening through study completion, up to 14 days]
Apparent total systemic clearance
- Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Vz/F [From screening through study completion, up to 14 days]
Apparent volume of distribution during the terminal elimination phase
- Pharmacokinetics (PK) parameter of ASC11 tablets in Urine: CLR [From screening through study completion, up to 14 days]
Renal clearance
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy male or female subjects aged 18-60 years (including boundary values)
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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])
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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.
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General good health based on history, physical examination (screening and check-in assessment), vital signs and other screening assessments.
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Able to understand the research content, comply with the research protocol, and voluntarily sign the informed consent.
Exclusion Criteria:
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Pregnant and lactating women.
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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.
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Any previous or existing hematological disorders or disorders, major liver disease, family history of bleeding/platelet disease.
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Previous or existing cancer (other than basal cell carcinoma or squamous cell carcinoma of the skin), or hygrosis.
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Have an autoimmune disease, immunosuppression, or any form of immune deficiency.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASC11-101