Healthy VolunteerPhase 1NCT05118516
Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects
A Phase 1 study testing ASC43F in people with Healthy Volunteer, run by Gannex Pharma Co., Ltd. at 1 site in United States.
Trial summary
This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ASC43F
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 7 Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female subjects between 18 to 65 years of age.
- Subjects must weigh at least 50 kg (110 pounds [lbs.]) for men, and at least 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-32 kilogram per meter square (kg/m2).
- Physical examination and vital signs are within normal range or slightly abnormal.
Who cannot join
- Any surgical or medical condition which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
- Abnormal clinical or laboratory findings that indicate diseases including but not limited to renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic disease.
- History or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases.
- History of viral hepatitis or HIV
- History of drug or food allergies that caused severe hypersensitivity reactions or anaphylaxis.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASC43F, a Fixed-dose Combination (FDC) Oral Tablet Containing ASC41, a THR β Agonist and ASC42, an FXR Agonist in Healthy Subjects
This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.
- Conditions
- Healthy Volunteer
- Being tested
- ASC43F
- Keywords
- ASC43F, Phase 1, Thyroid hormone receptor beta agonist, FXR agonist, ASC41, ASC42
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC43FDrug
One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | ASC43F for all subjects under the fasted state. Receives: Drug: ASC43F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).
Measured: Baseline to day 7
Secondary outcomes (3)
To evaluate the pharmacokinetics as assessed by Cmax (Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects
Measured: Baseline to day 4
To evaluate the pharmacokinetics as assessed by Area Under the Curve (AUC) of ASC43F tablet following a single fixed oral dose in healthy subjects
Measured: Baseline to day 4
To evaluate the pharmacokinetics as assessed by Tmax (Time to Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects
Measured: Baseline to day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start1 Nov 2021
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gannex Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118516
- Sponsor's protocol ID
- ASC43F-101
- Status last verified
- Sep 2024
- First submitted
- 31 Oct 2021
- Last updated
- 27 Sep 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASC43F, a Fixed-dose Combination (FDC) Oral Tablet Containing ASC41, a THR β Agonist and ASC42, an FXR Agonist in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05118516
- Acronym / sponsor ID
- ASC43F-101
- Conditions
- Healthy Volunteer
- Keywords
- ASC43F, Phase 1, Thyroid hormone receptor beta agonist, FXR agonist, ASC41, ASC42
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Gannex Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 12 Nov 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 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: ASC43FASC43F for all subjects under the fasted state. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female subjects between 18 to 65 years of age.
- Subjects must weigh at least 50 kg (110 pounds [lbs.]) for men, and at least 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-32 kilogram per meter square (kg/m2).
- Physical examination and vital signs are within normal range or slightly abnormal.
Key exclusion criteria (5 listed)
- Any surgical or medical condition which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
- Abnormal clinical or laboratory findings that indicate diseases including but not limited to renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic disease.
- History or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases.
- History of viral hepatitis or HIV
- History of drug or food allergies that caused severe hypersensitivity reactions or anaphylaxis.).
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 |
|---|---|---|
| ASC43FOne dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg. | Drug | Experimental |
Primary outcome
Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).
Time frame: Baseline to day 7
3 secondary outcomes
To evaluate the pharmacokinetics as assessed by Cmax (Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects
Time frame: Baseline to day 4
To evaluate the pharmacokinetics as assessed by Area Under the Curve (AUC) of ASC43F tablet following a single fixed oral dose in healthy subjects
Time frame: Baseline to day 4
To evaluate the pharmacokinetics as assessed by Tmax (Time to Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects
Time frame: Baseline to day 4
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 27 Sep 2024.
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Screening Protocol
Pain
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 ASC43F in people with Healthy Volunteer, run by Gannex Pharma Co., Ltd. at 1 site 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 3 inclusion and 5 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 27 Sep 2024. 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 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. 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?
Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs). (time frame: Baseline to day 7). 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 27 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.