SARS CoV 2 InfectionPhase 1NCT05596045
Study to Evaluate Safety, Tolerability, Efficacy and Pharmacokinetics of ASC10 in Mild to Moderate COVID-19 Patients
A Phase 1 study testing ASC10 in people with SARS CoV 2 Infection, run by Ascletis Pharmaceuticals Co., Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- ASC10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Nov 2022to 9 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pinnacle Research Group
Anniston, Alabama, 36207
Aga Clinical Trials
Hialeah, Florida, 33012
About this study
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
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.
- Conditions
- SARS CoV 2 Infection
- Being tested
- ASC10, Placebo
- Keywords
- ASC10, RdRp
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC10Drug
Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days
PlaceboDrug
Participants will be randomized to receive placebo
| Study group | Role | What they receive |
|---|---|---|
| ASC10 | Experimental | Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days Receives: Drug: ASC10 |
| Placebo | Placebo comparator | Participants will be randomized to receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment Emergent Adverse Event (TEAEs) in multiple ascending doses
Measured: 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
Measured: From Day 1 to Day 6
Secondary outcomes (1)
Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms
Measured: From Day 1 to Study Completion, up to 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start28 Nov 2022 (estimated)
- Primary completion8 Mar 2023 (estimated)
- Study completion9 Oct 2023 (estimated)
Why it stopped: This study has been cancelled due to business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596045
- Sponsor's protocol ID
- ASC10-102
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2022
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05596045
- Acronym / sponsor ID
- ASC10-102
- Conditions
- SARS CoV 2 Infection
- Keywords
- ASC10, RdRp
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been cancelled due to business reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (estimated)
- Primary completion
- 8 Mar 2023 (estimated)
- Study completion
- 9 Oct 2023 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASC10 | Experimental | Drug: ASC10Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC10Participants will be randomized to receive 200, 400 and 800 mg ASC10 BID for 5.5 days | Drug | ASC10 |
| PlaceboParticipants will be randomized to receive placebo | Drug | Placebo |
Primary outcome
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
PK parameters for ASC10, GLC01-700 (molnupiravir) and ASC10-A in plasma as AUC0-12h
Time frame: From Day 1 to Day 6
1 secondary outcome
Time (days) to sustained resolution of all targeted COVID-19 signs/symptoms
Time frame: From Day 1 to Study Completion, up to 32 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASC10 in people with SARS CoV 2 Infection, run by Ascletis Pharmaceuticals Co., Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.