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

November 11, 2024 updated by: Ascletis Pharmaceuticals Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital of Zhejiang University school of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) of ASC11 relative to placebo
Time Frame: 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.
From screening through study completion, up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Title Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-inf
Time Frame: From screening through study completion, up to 14 days
Area under the concentration-time curve from the time of dosing extrapolated to time infinity
From screening through study completion, up to 14 days
Title -Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Cmax
Time Frame: From screening through study completion, up to 14 days
Maximum concentration
From screening through study completion, up to 14 days
Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Tmax
Time Frame: From screening through study completion, up to 14 days
Time to Maximum Observed Plasma Concentration
From screening through study completion, up to 14 days
Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: AUC 0-t
Time Frame: 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
From screening through study completion, up to 14 days
Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: T1/2
Time Frame: From screening through study completion, up to 14 days
Elimination half-life
From screening through study completion, up to 14 days
Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: CL/F
Time Frame: From screening through study completion, up to 14 days
Apparent total systemic clearance
From screening through study completion, up to 14 days
Pharmacokinetics (PK) parameter of ASC11 tablets combined with Ritonavir tablets in Plasma: Vz/F
Time Frame: From screening through study completion, up to 14 days
Apparent volume of distribution during the terminal elimination phase
From screening through study completion, up to 14 days
Pharmacokinetics (PK) parameter of ASC11 tablets in Urine: CLR
Time Frame: From screening through study completion, up to 14 days
Renal clearance
From screening through study completion, up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2023

Primary Completion (Actual)

April 14, 2023

Study Completion (Actual)

April 14, 2023

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC11-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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