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

Sponsor

Ascletis Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05596045

Collaborator

(none)

Enrollment

Locations

Arms

10.3

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SARS CoV 2 Infection	Drug: ASC10 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 28, 2022

Anticipated Primary Completion Date :

Mar 8, 2023

Anticipated Study Completion Date :

Oct 9, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASC10 Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days	Drug: ASC10 Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
Placebo Comparator: Placebo Participants will be randomized to receive placebo	Drug: Placebo Participants will be randomized to receive placebo

Arm

Intervention/Treatment

Experimental: ASC10

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

Drug: ASC10

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

Placebo Comparator: Placebo

Participants will be randomized to receive placebo

Drug: Placebo

Participants will be randomized to receive placebo

Outcome Measures

Primary Outcome Measures

Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses [From Day 0 to Study Completion, up to 32 days]
PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h [From Day 1 to Day 6]

Secondary Outcome Measures

Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms [From Day 1 to Study Completion, up to 32 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Research Group	Anniston	Alabama	United States	36207
2	Aga Clinical Trials	Hialeah	Florida	United States	33012

Sponsors and Collaborators

Ascletis Pharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ascletis Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05596045

Other Study ID Numbers:

ASC10-102

First Posted:

Oct 27, 2022

Last Update Posted:

Oct 31, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ascletis Pharmaceuticals Co., Ltd.

ASC10

RdRp

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 31, 2022