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

Healthy Clinical Trial

Official title:

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of ASC11/RTV Tablets and Study to Evaluate the Effects of Food on the PK of ASC11/RTV Tablets in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718518
• Other study ID #: ASC11-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 13, 2023
• Est. completion date: April 10, 2023

Study information

• Verified date: February 2023
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: Yunqing Qiu
• Phone: +8613588189339
• Email: qiuyq[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 10, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Healthy

Intervention

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)
• Placebo
Part 1 and 2: Subjects will be randomized to receive placebo.
• 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)

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) of ASC11 relative to placebo	To evaluate the safety and tolerability of ASC11 tablets combined with Ritonavir tablets in healthy subjects given single and multiple dose increments.	From screening through study completion, up to 14 days
Secondary	Title Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-inf	Area under the concentration-time curve from the time of dosing extrapolated to time infinity	From screening through study completion, up to 14 days
Secondary	Title -Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Cmax	Maximum concentration	From screening through study completion, up to 14 days
Secondary	Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Tmax	Time to Maximum Observed Plasma Concentration	From screening through study completion, up to 14 days
Secondary	Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-t	Area under the concentration-time curve from the time of dosing to the last measurable concentration	From screening through study completion, up to 14 days
Secondary	Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: T1/2	Elimination half-life	From screening through study completion, up to 14 days
Secondary	Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: CL/F	Apparent total systemic clearance	From screening through study completion, up to 14 days
Secondary	Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Vz/F	Apparent volume of distribution during the terminal elimination phase	From screening through study completion, up to 14 days
Secondary	Pharmacokinetics (PK) parameter of ASC11 tablets in Urine: CLR	Renal clearance	From screening through study completion, up to 14 days