A Phase I Study of Single and Multiple Doses of HS-20136-2 Injection in Healthy or Obese Participants

NCT07716241 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20136-2-102
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-20136-2 injection in healthy/obese participants.

Conditions

Obesity

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  A summary of adverse events, including Serious Adverse Events(SAEs)

  Start of Treatment to end of study (approximately 57 days or 112 days)

Secondary Outcomes (4)

• Area under the plasma concentration-time curve (AUC) of HS-20136-2

  Start of Treatment to end of study (approximately 57 days)

• AUC of HS-20136-2

  Start of Treatment to end of study (approximately 112 days)

• Immunogenicity

  Start of Treatment to end of study (approximately 112 days)

• body weight change

  Start of Treatment to end of study (approximately 112 days)

Study Arms (2)

HS-20136-2

EXPERIMENTAL

Subcutaneous injection once，Subcutaneous injection three times

Drug: HS-20136-2

placebo

PLACEBO COMPARATOR

Subcutaneous injection once，Subcutaneous injection three times

Drug: Placebo

Interventions

HS-20136-2 DRUG

Single-dose pen of HS-20136-2 injection solution

HS-20136-2

placebo DRUG

Single-dose of placebo

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 55 years (inclusive) at screening, male or female.
• Participants must fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the informed consent form (ICF) prior to any study-related procedures.
• Agree to use effective contraceptive measures and refrain from sperm or egg donation from the time of signing the ICF until 4 months after the last dose.
• Agree to abstain from alcohol, smoking, and food or beverages containing xanthine or caffeine (including chocolate, tea, coffee, cola, etc.), and refrain from strenuous exercise from 48 hours prior to dosing until discharge from the study site.
• Self-reported body weight fluctuation of ≤ 5.0% within 12 weeks prior to screening through diet and exercise control alone.
• Willing and able to maintain a stable diet and exercise lifestyle throughout the study period.
• SAD cohort: body weight ≥ 50 kg, BMI 19.0-28.0 kg/m² (inclusive). MAD cohort: BMI 28.0-40.0 kg/m² (inclusive).

You may not qualify if:

• History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, psychiatric, neurological, hematological, immunological, or metabolic disorders (e.g., recurrent hypoglycemia of unknown cause) that, in the investigator's opinion, would make the participant unsuitable for participation in this study.
• Clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.
• Presence of diseases that, in the investigator's judgment, may significantly affect drug or nutrient absorption, including clinically significant gastrointestinal disorders (e.g., active inflammatory bowel disease) or symptoms of gastrointestinal disturbance; or any condition that may affect drug absorption, such as subtotal or total gastrectomy, sleeve gastrectomy, gastric bypass surgery, or resection of any intestinal segment.
• Diagnosis of chronic pancreatitis or history of idiopathic acute pancreatitis, or serum amylase or lipase above the upper limit of normal (ULN) at screening. Participants with a history of acute pancreatitis due to cholelithiasis may be enrolled if they have undergone cholecystectomy.
• History of acute cholecystitis, or presence of symptomatic/stone-related cholelithiasis requiring treatment on prior or screening ultrasound (except for participants who have undergone cholecystectomy and are deemed eligible by the investigator).
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2), or screening calcitonin level ≥ 50 ng/L.
• Participation in any other clinical trial of a drug or medical device within 3 months prior to screening (excluding those who did not receive the investigational product or device).
• History of diabetes mellitus (type 1, type 2, or rare forms of diabetes).
• Presence of endocrine disorders or history thereof that may significantly affect body weight (e.g., Cushing's syndrome, hypothyroidism, or hyperthyroidism; except for hypothyroidism managed with a stable thyroid hormone replacement regimen for at least 6 months), or obesity due to single-gene mutations or hereditary obesity syndromes.
• Use of any medication or treatment known to cause significant weight gain or weight loss within 3 months prior to screening.
• Any other condition that, in the investigator's opinion, would make the participant unsuitable for enrollment in this study.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Hospital of Ahui Medical University

Hefei, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wei Hu

CONTACT

13856086475; huwei@ahmu.edu.com

Renpeng Zhou

CONTACT

15956933545; zhourenpeng@ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 22, 2026
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

CN (1)