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Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients

Primary Purpose

SARS CoV 2 Infection

Status

Not yet recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ASC10

Placebo

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects aged ≥18 years at screening;
Those females 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;
Has a documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤5 days prior to randomization.

Exclusion Criteria:

Females who are pregnant, planning to become pregnant, or breastfeeding;
Has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from COVID-19;
Has hypersensitivity or other contraindication to any of the components of the study interventions;
Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.

Sites / Locations

Pinnacle Research Group
Aga Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASC10

Placebo

Arm Description

Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days

Participants will be randomized to receive placebo

Outcomes

Primary Outcome Measures

Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses

PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h

Secondary Outcome Measures

Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms

Full Information

NCT ID

NCT05596045

First Posted

October 25, 2022

Last Updated

October 28, 2022

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05596045

Brief Title

Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients

Official Title

A Phase Ib, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 Tablets in Mild or Moderate COVID-19 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 28, 2022 (Anticipated)

Primary Completion Date

March 8, 2023 (Anticipated)

Study Completion Date

October 9, 2023 (Anticipated)

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

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase Ib, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, efficacy and pharmacokinetics of ASC10 tablets in mild or moderate COVID-19 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASC10

Arm Type

Experimental

Arm Description

Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will be randomized to receive placebo

Intervention Type

Drug

Intervention Name(s)

ASC10

Intervention Description

Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will be randomized to receive placebo

Primary Outcome Measure Information:

Title

Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses

Time Frame

From Day 0 to Study Completion, up to 32 days

Title

PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h

Time Frame

From Day 1 to Day 6

Secondary Outcome Measure Information:

Title

Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms

Time Frame

From Day 1 to Study Completion, up to 32 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects aged ≥18 years at screening; Those females 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; Has a documentation of PCR-confirmed SARS-CoV-2 infection with sample collection ≤5 days prior to randomization. Exclusion Criteria: Females who are pregnant, planning to become pregnant, or breastfeeding; Has at least one characteristic or underlying medical condition associated with an increased risk of developing severe or critical illness from COVID-19; Has hypersensitivity or other contraindication to any of the components of the study interventions; Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Handan He, Doctor

Phone

+8657185389730

handan.he@ascletis.com

Facility Information:

Facility Name

Pinnacle Research Group

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Aga Clinical Trials

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberto Aguirre

Phone

305-819-6990

RAGUIRRE@AGACLINICALTRIALS.COM

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients

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