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

Primary Purpose

SARS CoV 2 Infection

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ASC10
Placebo
Sponsored by
Ascletis Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS CoV 2 Infection focused on measuring ASC10, RdRp, Healthy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASC10

Placebo

Arm Description

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)

Part 1: Participants will be randomized to receive placebo

Outcomes

Primary Outcome Measures

Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)
Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD
Vital signs evaluation includes: systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate.
Part1: Number of Participants With Laboratory Abnormalities in MAD

Secondary Outcome Measures

Full Information

First Posted
August 30, 2022
Last Updated
December 15, 2022
Sponsor
Ascletis Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05523141
Brief Title
Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascletis Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV 2 Infection
Keywords
ASC10, RdRp, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASC10
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Part 1: Participants will be randomized to receive placebo
Intervention Type
Drug
Intervention Name(s)
ASC10
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Part 1: Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner
Primary Outcome Measure Information:
Title
Part1: Number of participants with Treatment Emergent Adverse Events (TEAEs) in multiple ascending dose (MAD)
Time Frame
From screening through study completion, up to 12 days
Title
Part1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs in MAD
Description
Vital signs evaluation includes: systolic and diastolic blood pressure (BP), temperature, respiratory rate and pulse rate.
Time Frame
From screening through study completion, up to 12 days
Title
Part1: Number of Participants With Laboratory Abnormalities in MAD
Time Frame
From screening through study completion, up to 12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunqing Qiu, Master
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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