New drug HS-20136-2 enters first human safety trial

NCT ID NCT07483437

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug, HS-20136-2, in 38 healthy adults to see if it is safe and how the body handles it. Participants receive a single injection of either the drug or a placebo, and researchers monitor for side effects and measure drug levels in the blood. Since this is a Phase 1 trial, it focuses on safety and dosing, not on treating any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HS-20136-2 injection
What could go wrong
This is a very early Phase 1 study in only 38 healthy people, so it cannot prove the drug works for any disease. The main goal is just safety, not treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants who are able to sufficiently understand the study content, process, and potential adverse reactions, and voluntarily sign the informed consent form; 2. Healthy men and women aged 18-65 years (inclusive); 3. Body weight ≥ 50 kg (male) or ≥ 45 kg (female) and body mass index (BMI) within the range of 25-35 (inclusive) \[BMI = body weight/body height2 (kg/m2)\]; Exclusion Criteria: 1. Pregnant or lactating women; 2. 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. 3. 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; 4. 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); 5. 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; 6. Treatment with systemic steroids, immunomodulators, or chemotherapy within 3 months before screening or likely to receive them during the study; 7. Known severe allergic disease, or known allergies to GLP-1R agonists or Retatrutide, or allergic constitution (allergies to various drugs and foods); 8. 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; 9. 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; 10. 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; 11. 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; 12. Other reasons for exclusion, as determined by the investigator.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • CMAX Clinical Research Pty Ltd

    Adelaide, South Australia, 5000, Australia

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