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Completed

NCT Number: NCT05718518

Study to Evaluate Safety, Tolerability, PK and the Food Effect on 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

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Key information

Conditions

Healthy COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC11 tablets

Drug

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

Drug

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

RTV tablets

Drug

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Pharmacokinetics (PK) parameter of ASC11 tablets in Urine: CLR

    Time frame: From screening through study completion, up to 14 days

    Renal clearance

Sponsors and collaborators

Lead sponsor

Ascletis Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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