HealthyPhase 1NCT04965337
Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
A Phase 1 study testing ASC42 in people with Healthy, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ASC42
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2021to 1 Aug 2021
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers aged 18-55 years.
- 19kg/m2 ≤ BMI <24kg/m2.
Who cannot join
- A positive HBsAg, HCV Ab and/or HIV Ab.
- Pancreatic injury or pancreatitis.
- History of organ transplantation, including bone marrow transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.
- Conditions
- Healthy
- Being tested
- ASC42, Placebo
- Keywords
- Healthy Subjects, ASC42, FXR agonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC42Drug
ASC42 tablet administered orally
PlaceboDrug
Matching placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| ASC42 Dose A | Experimental | ASC42 tablet Dose A, once daily Receives: Drug: ASC42 |
| Placebo Dose A | Placebo comparator | Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily Receives: Drug: Placebo |
| ASC42 Dose B | Experimental | ASC42 tablet Dose B, once daily Receives: Drug: ASC42 |
| Placebo Dose B | Placebo comparator | Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of ASC42
Evaluate the Area under the plasma concentration versus time curve.
Measured: Up to 4 days
Cmax of ASC42
Evaluate the Peak Plasma Concentration.
Measured: Up to 4 days
Secondary outcomes (4)
t1/2 of ASC42
Evaluate the Terminal-Phase Half-Life.
Measured: Up to 4 days
CL/F of ASC42
Evaluate the Apparent Systemic Clearance.
Measured: Up to 4 days
Vd/F of ASC42
Evaluate the Apparent Volume of Distribution.
Measured: Up to 4 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 7 days.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start11 Jul 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 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
- NCT04965337
- Sponsor's protocol ID
- ASC42-102
- Status last verified
- Jun 2022
- First submitted
- 7 Jul 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT04965337
- Acronym / sponsor ID
- ASC42-102
- Conditions
- Healthy
- Keywords
- Healthy Subjects, ASC42, FXR agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ascletis Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 16 Jul 2021 (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 I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASC42 Dose A | Experimental | Drug: ASC42ASC42 tablet Dose A, once daily |
| Placebo Dose A | Placebo comparator | Drug: PlaceboPlacebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily |
| ASC42 Dose B | Experimental | Drug: ASC42ASC42 tablet Dose B, once daily |
| Placebo Dose B | Placebo comparator | Drug: PlaceboPlacebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female volunteers aged 18-55 years.
- 19kg/m2 ≤ BMI <24kg/m2.
Key exclusion criteria (3 listed)
- A positive HBsAg, HCV Ab and/or HIV Ab.
- Pancreatic injury or pancreatitis.
- History of organ transplantation, including bone marrow transplantation.
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 |
|---|---|---|
| ASC42ASC42 tablet administered orally | Drug | ASC42 Dose A, ASC42 Dose B |
| PlaceboMatching placebo administered orally | Drug | Placebo Dose A, Placebo Dose B |
Primary outcome
AUC of ASC42
Time frame: Up to 4 days
Evaluate the Area under the plasma concentration versus time curve.
Cmax of ASC42
Time frame: Up to 4 days
Evaluate the Peak Plasma Concentration.
4 secondary outcomes
t1/2 of ASC42
Time frame: Up to 4 days
CL/F of ASC42
Time frame: Up to 4 days
Vd/F of ASC42
Time frame: Up to 4 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASC42 in people with Healthy, run by Ascletis Pharmaceuticals Co., Ltd. at 1 site in China.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC of ASC42 (time frame: Up to 4 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 30 Jun 2022.