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

Phase 1

Completed

• Conditions: Healthy; COVID-19
• Interventions: Drug: RTV tablets; Drug: ASC11 tablets; Drug: Placebo

• Registration Number: NCT05718518
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-06
• Study Start: 2023-01-13
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RTV tablets	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)
ASC11 tablets	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)
Placebo	Placebo	Part 1 and 2: Subjects will be randomized to receive placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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: 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
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 in Urine: CLR	From screening through study completion, up to 14 days	Renal clearance
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: Vz/F	From screening through study completion, up to 14 days	Apparent volume of distribution during the terminal elimination phase

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China