Chronic Weight ManagementPhase 1NCT06427590
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects
A Phase 1 study testing ASC47 in people with Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 1 site in Australia.
Trial summary
This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Weight Management
- What is being tested?
- ASC47
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Jul 2024to 31 Dec 2024
- 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
- Subject have provided informed consent before initiation of any study-specific procedures
- Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
- Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.
Who cannot join
- Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
- Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
- Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
- Have a history of febrile illness within 14 days prior to screening.
- Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
- Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy and Obese Subjects
This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.
- Conditions
- Chronic Weight Management
- Being tested
- ASC47, Matching placebo
- Keywords
- ASC47
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC47Drug
single subcutaneous injection of ASC47
Matching placeboDrug
single subcutaneous injection of Placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD in healthy subjects-Cohort 1 | Experimental | SAD cohort 1, dose 1 Receives: Drug: ASC47; Drug: Matching placebo |
| SAD in healthy subjects-Cohort 2 | Experimental | SAD Cohort 2, dose 2 Receives: Drug: ASC47; Drug: Matching placebo |
| SAD in healthy subjects-Cohort 3 | Experimental | SAD Cohort 3, dose 3 Receives: Drug: ASC47; Drug: Matching placebo |
| SAD in patients with obesity-Cohort 3A | Experimental | SAD Cohort 3A, dose 3 Receives: Drug: ASC47; Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.
Measured: up to 57 days
ECG QT Interval
Evaluate the ECG QT Interval after single doses of ASC47.
Measured: up to 57 days
Blood cell
Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.
Measured: up to 57 days
Hematology
Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.
Measured: up to 57 days
Secondary outcomes (7)
AUC of ASC47
Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.
Measured: up to 57 days
Cmax of ASC47
Evaluate the Peak Plasma Concentration after single doses of ASC47.
Measured: up to 57 days
Cmin of ASC47
Evaluate the Minimum Plasma Concentration after single doses of ASC47.
Measured: up to 57 days
T1/2 of ASC47
Evaluate the Terminal-Phase Half-Life after single doses of ASC47
Measured: up to 57 days
CL/F of ASC47
Evaluate the Apparent Systemic Clearance after single doses of ASC47.
Measured: up to 57 days
Vd/F of ASC47
Evaluate the Apparent Volume of Distribution after single doses of ASC47.
Measured: up to 57 days
Lipid parameters
Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.
Measured: up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start13 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Weight ManagementStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascletis Pharma (China) Co., Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427590
- Sponsor's protocol ID
- ASC47-101
- Status last verified
- Sep 2024
- First submitted
- 10 May 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy and Obese Subjects
- ClinicalTrials.gov ID
- NCT06427590
- Acronym / sponsor ID
- ASC47-101
- Conditions
- Chronic Weight Management
- Keywords
- ASC47
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ascletis Pharma (China) Co., LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 May 2024 (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 will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
This study aims to evaluate the pharmacokinetics and target engagement of ASC47 in healthy and obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAD in healthy subjects-Cohort 1 | Experimental | Drug: ASC47, Drug: Matching placeboSAD cohort 1, dose 1 |
| SAD in healthy subjects-Cohort 2 | Experimental | Drug: ASC47, Drug: Matching placeboSAD Cohort 2, dose 2 |
| SAD in healthy subjects-Cohort 3 | Experimental | Drug: ASC47, Drug: Matching placeboSAD Cohort 3, dose 3 |
| SAD in patients with obesity-Cohort 3A | Experimental | Drug: ASC47, Drug: Matching placeboSAD Cohort 3A, dose 3 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject have provided informed consent before initiation of any study-specific procedures
- Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
- Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.
Key exclusion criteria (7 listed)
- Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
- Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
- Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
- Have a history of febrile illness within 14 days prior to screening.
- Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
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 |
|---|---|---|
| ASC47single subcutaneous injection of ASC47 | Drug | SAD in healthy subjects-Cohort 1, SAD in healthy subjects-Cohort 2, SAD in healthy subjects-Cohort 3, SAD in patients with obesity-Cohort 3A |
| Matching placebosingle subcutaneous injection of Placebo | Drug | SAD in healthy subjects-Cohort 1, SAD in healthy subjects-Cohort 2, SAD in healthy subjects-Cohort 3, SAD in patients with obesity-Cohort 3A |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 57 days
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.
ECG QT Interval
Time frame: up to 57 days
Evaluate the ECG QT Interval after single doses of ASC47.
Blood cell
Time frame: up to 57 days
Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.
Hematology
Time frame: up to 57 days
Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.
7 secondary outcomes
AUC of ASC47
Time frame: up to 57 days
Cmax of ASC47
Time frame: up to 57 days
Cmin of ASC47
Time frame: up to 57 days
T1/2 of ASC47
Time frame: up to 57 days
CL/F of ASC47
Time frame: up to 57 days
Vd/F of ASC47
Time frame: up to 57 days
Lipid parameters
Time frame: up to 57 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 11 May 2025.
- Individual participant dataSharing planned: No
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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 ASC47 in people with Chronic Weight Management, run by Ascletis Pharma (China) Co., Limited at 1 site in Australia.
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 7 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 11 May 2025. 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 Australia. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: up to 57 days). The study lists 4 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 11 May 2025.