Clinical trial NCT05718518: Study to Evaluate Safety, Tolerability, PK and the Food Effect on PK of ASC11/RTV Tablets in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
COVID-19
Keywords: COVID-19
ASC11
3CL-pro
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) of ASC11 relative to placebo
timeFrame: From screening through study completion, up to 14 days
Secondary outcomes:
measure: Title Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-inf
timeFrame: From screening through study completion, up to 14 days
measure: Title -Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Cmax
timeFrame: From screening through study completion, up to 14 days
measure: Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Tmax
timeFrame: From screening through study completion, up to 14 days
measure: Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-t
timeFrame: From screening through study completion, up to 14 days
measure: Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: T1/2
timeFrame: From screening through study completion, up to 14 days
measure: Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: CL/F
timeFrame: From screening through study completion, up to 14 days
measure: Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Vz/F
timeFrame: From screening through study completion, up to 14 days
measure: Pharmacokinetics (PK) parameter of ASC11 tablets in Urine: CLR
timeFrame: From screening through study completion, up to 14 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: