HealthyPhase 1NCT07483437
A Study of HS-20136-2 in Healthy Participants
A Phase 1 study testing HS-20136-2 injection in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in Australia.
Trial summary
This is a randomized, double-blind,placebo-controlled phase I clinical study.The main purpose is to assess the safety and tolerability of single subcutaneous administration of HS-20136-2 injection in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HS-20136-2 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteAustralia
- Study dates
- 15 May 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants who are able to sufficiently understand the study content, process, and potential adverse reactions, and voluntarily sign the informed consent form;
- Healthy men and women aged 18-65 years (inclusive);
- Body weight ≥ 50 kg (male) or ≥ 45 kg (female) and body mass index (BMI) within the range of 25-35 (inclusive) [BMI = body weight/body height2 (kg/m2)];
Who cannot join
- Pregnant or lactating women;
- Participants with a history of cardiovascular, respiratory, hepatic, renal, digestive tract, mental, neurological, hematological, immune, and metabolic abnormalities (such as unexplained recurrent hypoglycemia) and other diseases, and not suitable for the study as assessed by the investigator, such as: Childhood asthma (resolved),Depression (non-hospitalised, but potentially medicated in the past), Migraine, etc.
- Glycosylated hemoglobin A1c (HbA1c) > 6.5% or fasting blood glucose ≤ 3.9 mmol/L (70 mg/dL) or ≥ 6.1 mmol/L (110 mg/dL) during the screening period;
- The alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin (TBIL) > 1.5 × ULN during the screening period (except for cases of known Gilbert's Syndrome);
- Participating in any clinical study involving drugs or medical devices (except for those not receiving an investigational drug or investigational device) within 3 months before screening or 5 half-lives (whichever is longer) before screening, or currently participating in a clinical trial;
- Treatment with systemic steroids, immunomodulators, or chemotherapy within 3 months before screening or likely to receive them during the study;
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- Known severe allergic disease, or known allergies to GLP-1R agonists or Retatrutide, or allergic constitution (allergies to various drugs and foods);
- With concomitant diseases that may significantly affect the absorption of drugs or nutrients as judged by the investigator, such as clinically significant gastrointestinal diseases (e.g., active inflammatory bowel disease) and symptoms of gastrointestinal disorders; or any condition that might affect the absorption of drugs, such as subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery, and resection of any intestinal area;
- History of confirmed chronic pancreatitis or idiopathic acute pancreatitis, or serum amylase or lipase greater than the upper limit of normal at screening. A participant with a history of acute pancreatitis caused by gallstones may be included in the study if the participant has a cholecystectomy to resolve the problem;
- Have a history of symptomatic gallbladder disease within the past 2 years, defined by the presence of gallstones on an imaging study and abdominal pain attributed to the gallstones by the participant's physician; subjects who had a procedure to remove the gallstones and/or the gallbladder (cholecystectomy), with no long-term complications, are eligible for participation as long as the procedure was completed at least 3 months prior to screening;
- Diet or weight loss treatment within 3 months prior to administration (regardless of the reason) or having body weight change of more than 5% or a significant change in living habits within 3 months prior to administration;
- Other reasons for exclusion, as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
Eloise Amy Mitchell, BHSc (Hons), +61 8 7088 7999, eloise.mitchell@cmax.com.au
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Administration of HS-20136-2 Injection in Healthy Participants
This is a randomized, double-blind,placebo-controlled phase I clinical study.The main purpose is to assess the safety and tolerability of single subcutaneous administration of HS-20136-2 injection in healthy participants.
Read the detailed description
This is a phase I, double-blind, randomised, placebo-controlled trial to assess the safety and tolerability of HS-20136-2 in healthy participants. We enrolled adults (aged 18-65 years, both inclusive) with body-mass index [BMI] ≥25 kg/m2 and ≤35 kg/m2 in Australia. Eligible participants were randomly assigned to receive a single dose subcutaneous injection of HS-20136-2 or placebo. The primary endpoint is：
- Incidence, severity, and relationship to the investigational products of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal from the study;
- Changes in laboratory tests (hematology, urinalysis, blood biochemistry, coagulation function, etc.), vital signs, ECG results, etc., before and after administration.
- Conditions
- Healthy
- Being tested
- HS-20136-2 injection, HS-20136-2 injection Placebo
- Keywords
- HS-20136-2，single ascending dose，safety，tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20136-2 injectionDrug
Administrated SC
HS-20136-2 injection PlaceboDrug
Administrated SC
| Study group | Role | What they receive |
|---|---|---|
| HS-20136-2 injection | Experimental | Escalating doses of HS-20136-2 administered subcutaneously (SC) once in healthy participants. Receives: Drug: HS-20136-2 injection |
| HS-20136-2 injection Placebo | Placebo comparator | Placebo administered SC once in healthy participants Receives: Drug: HS-20136-2 injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event (AE)
A summary of AEs
Measured: Time of Inform Consent Form to Day 57
Incidence of serious adverse event (SAE)
A summary of SAEs
Measured: Time of Inform Consent Form to Day 57
AE leading to study discontinuation
AE leading to study discontinuation
Measured: Time of Inform Consent Form to Day 57
AE severity and relation with study drug
AE severity and relation with study drug will be reported in the reported adverse events module
Measured: Time of Inform Consent Form to Day 57
Secondary outcomes (5)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)
PK: AUC
Measured: Baseline to Day 57
Pharmacodynamics (PD): glucose change
Changes in fasting blood glucose
Measured: Baseline to Day 57
Pharmacokinetics (PK): Tmax
PK: Tmax
Measured: Baseline to Day 57
Pharmacokinetics (PK): Cmax of HS-20136-2
PK: Cmax of HS-20136-2
Measured: Baseline to Day 57
Pharmacodynamics (PD):weight change
Changes in body weight
Measured: Baseline to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483437
- Sponsor's protocol ID
- HS-20136-2-101
- Status last verified
- Feb 2026
- First submitted
- 12 Mar 2026
- Last updated
- 1 Jun 2026
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Administration of HS-20136-2 Injection in Healthy Participants
- ClinicalTrials.gov ID
- NCT07483437
- Acronym / sponsor ID
- HS-20136-2-101
- Conditions
- Healthy
- Keywords
- HS-20136-2，single ascending dose，safety，tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (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 randomized, double-blind,placebo-controlled phase I clinical study.The main purpose is to assess the safety and tolerability of single subcutaneous administration of HS-20136-2 injection in healthy participants.
Detailed description
This is a phase I, double-blind, randomised, placebo-controlled trial to assess the safety and tolerability of HS-20136-2 in healthy participants. We enrolled adults (aged 18-65 years, both inclusive) with body-mass index [BMI] ≥25 kg/m2 and ≤35 kg/m2 in Australia. Eligible participants were randomly assigned to receive a single dose subcutaneous injection of HS-20136-2 or placebo. The primary endpoint is：
- Incidence, severity, and relationship to the investigational products of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal from the study;
- Changes in laboratory tests (hematology, urinalysis, blood biochemistry, coagulation function, etc.), vital signs, ECG results, etc., before and after administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20136-2 injection | Experimental | Drug: HS-20136-2 injectionEscalating doses of HS-20136-2 administered subcutaneously (SC) once in healthy participants. |
| HS-20136-2 injection Placebo | Placebo comparator | Drug: HS-20136-2 injection PlaceboPlacebo administered SC once in healthy participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who are able to sufficiently understand the study content, process, and potential adverse reactions, and voluntarily sign the informed consent form;
- Healthy men and women aged 18-65 years (inclusive);
- Body weight ≥ 50 kg (male) or ≥ 45 kg (female) and body mass index (BMI) within the range of 25-35 (inclusive) [BMI = body weight/body height2 (kg/m2)];
Key exclusion criteria (12 listed)
- Pregnant or lactating women;
- Participants with a history of cardiovascular, respiratory, hepatic, renal, digestive tract, mental, neurological, hematological, immune, and metabolic abnormalities (such as unexplained recurrent hypoglycemia) and other diseases, and not suitable for the study as assessed by the investigator, such as: Childhood asthma (resolved),Depression (non-hospitalised, but potentially medicated in the past), Migraine, etc.
- Glycosylated hemoglobin A1c (HbA1c) > 6.5% or fasting blood glucose ≤ 3.9 mmol/L (70 mg/dL) or ≥ 6.1 mmol/L (110 mg/dL) during the screening period;
- The alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin (TBIL) > 1.5 × ULN during the screening period (except for cases of known Gilbert's Syndrome);
- Participating in any clinical study involving drugs or medical devices (except for those not receiving an investigational drug or investigational device) within 3 months before screening or 5 half-lives (whichever is longer) before screening, or currently participating in a clinical trial;
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 |
|---|---|---|
| HS-20136-2 injectionAdministrated SC | Drug | HS-20136-2 injection |
| HS-20136-2 injection PlaceboAdministrated SC | Drug | HS-20136-2 injection Placebo |
Primary outcome
Incidence of adverse event (AE)
Time frame: Time of Inform Consent Form to Day 57
A summary of AEs
Incidence of serious adverse event (SAE)
Time frame: Time of Inform Consent Form to Day 57
A summary of SAEs
AE leading to study discontinuation
Time frame: Time of Inform Consent Form to Day 57
AE leading to study discontinuation
AE severity and relation with study drug
Time frame: Time of Inform Consent Form to Day 57
AE severity and relation with study drug will be reported in the reported adverse events module
5 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)
Time frame: Baseline to Day 57
Pharmacodynamics (PD): glucose change
Time frame: Baseline to Day 57
Pharmacokinetics (PK): Tmax
Time frame: Baseline to Day 57
Pharmacokinetics (PK): Cmax of HS-20136-2
Time frame: Baseline to Day 57
Pharmacodynamics (PD):weight change
Time frame: Baseline to Day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
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 HS-20136-2 injection in people with Healthy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. 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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 1 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Metodey Polasek, PhD(Clinical.Pharmacology) (+61 458 162 715, cmax@cmax.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event (AE) (time frame: Time of Inform Consent Form to Day 57). 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 1 Jun 2026.