A Study of HS-20136-2 in Healthy Participants

NCT07483437 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20136-2-101
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

HS-20136-2，single ascending dose，safety，tolerability

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse event (AE)

  A summary of AEs

  Time of Inform Consent Form to Day 57

• Incidence of serious adverse event (SAE)

  A summary of SAEs

  Time of Inform Consent Form to Day 57

• AE leading to study discontinuation

  AE leading to study discontinuation

  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

  Time of Inform Consent Form to Day 57

Secondary Outcomes (5)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)

  Baseline to Day 57

• Pharmacodynamics (PD): glucose change

  Baseline to Day 57

• Pharmacokinetics (PK): Tmax

  Baseline to Day 57

• Pharmacokinetics (PK): Cmax of HS-20136-2

  Baseline to Day 57

• Pharmacodynamics (PD):weight change

  Baseline to Day 57

Study Arms (2)

HS-20136-2 injection

EXPERIMENTAL

Escalating doses of HS-20136-2 administered subcutaneously (SC) once in healthy participants.

Drug: HS-20136-2 injection

HS-20136-2 injection Placebo

PLACEBO COMPARATOR

Placebo administered SC once in healthy participants

Drug: HS-20136-2 injection Placebo

Interventions

HS-20136-2 injection DRUG

Administrated SC

HS-20136-2 injection

HS-20136-2 injection Placebo DRUG

Administrated SC

HS-20136-2 injection Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[BMI = body weight/body height2 (kg/m2)\];

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

Central Study Contacts

Thomas Metodey Polasek, PhD(Clinical.Pharmacology)

CONTACT

+61 458 162 715; Thomas.Polasek@cmax.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 19, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-02

Locations

AU (1)