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Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects

NCT ID: NCT05523141

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2022-12-05

Brief Summary

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This is a phase I, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of ASC10 tablets and an open-label, crossover design to evaluate the food effect on PK of ASC10 in healthy subjects

Detailed Description

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Conditions

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SARS CoV 2 Infection

Keywords

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ASC10 RdRp Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASC10

Part 1: Participants will be randomized to receive 100 to 1600 mg ASC10 (including 6 cohorts) in an double-blind manner

Part 2: Participants will be randomized to receive two single 800 mg doses (fed or fasted)

Group Type EXPERIMENTAL

ASC10

Intervention Type DRUG

Part 1:

Participants will be randomized to receive twice daily dosing either ASC10 or Placebo for 5.5 days, in an double-blind manner

Part 2:

Two single oral doses of ASC10 will be administered to participants, in an open-label manner

Placebo

Part 1: Participants will be randomized to receive placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Part 1:

Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner

Interventions

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ASC10

Part 1:

Participants will be randomized to receive twice daily dosing either ASC10 or Placebo for 5.5 days, in an double-blind manner

Part 2:

Two single oral doses of ASC10 will be administered to participants, in an open-label manner

Intervention Type DRUG

Placebo

Part 1:

Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female volunteers between the ages 18 and 45, inclusive
* Those who do not have plans for pregnancy within six months and are willing to take effective contraceptive measures from the first dose of the study drug to 3 months after the last dose.
* If male, agree to use adequate contraception throughout the study and for at least 3 months after the last dose of study drug.
* Body mass index (BMI) was between 19 and 26 kg/m\^2. Weight ≥50 kg for males and ≥45 kg for females.

Exclusion Criteria

* Females who are pregnant, planning to become pregnant, or breastfeeding.
* Has any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
* Has a history of cancer (other than basal cell or squamous cell cancer of the skin), rheumatologic disease or blood dyscrasias.
* Has a history of blood dizziness or difficulty in blood collection.
* Has donated blood within 30 days, plasma within 2 weeks, or platelets within 6 weeks before the first dose of study drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yunqing Qiu, Master

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

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The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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Liu J, Zhao Q, Zhai Y, Wu X, Kai J, Ruan J, Wu M, Wu M, Zhou Z, Yan Y, Wu JJ, Qiu Y. Safety, tolerability and pharmacokinetics of ASC10, a novel oral double prodrug of a broad-spectrum antiviral agent, beta-d-N4-hydroxycytidine: results from a randomized, double-blind, placebo-controlled phase 1 study in Chinese healthy subjects. Expert Opin Investig Drugs. 2024 Aug;33(8):867-876. doi: 10.1080/13543784.2024.2377318. Epub 2024 Jul 12.

Reference Type DERIVED
PMID: 38988285 (View on PubMed)

Other Identifiers

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ASC10-101

Identifier Type: -

Identifier Source: org_study_id