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

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Administration of HS-20136-2 Injection in Healthy/Obese Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: HS-20136-2; Drug: HS-20136-2; Drug: placebo

Detailed Description

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Administration of HS-20136-2 Injection in Healthy/Obese Participants

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Hu; Phone Number: 13856086475; Email: huwei@ahmu.edu.com
• Study Contact Backup: Name: Renpeng Zhou; Phone Number: 15956933545; Email: zhourenpeng@ahmu.edu.cn

Study Locations

• China
  • Hefei, China
    • The Second Hospital of Ahui Medical University
    • Contact: jing zhang; Phone Number: 0551-63806098; Email: aydefyllwyhbgs@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Aged between 18 and 55 years (inclusive) at screening, male or female.
2. 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.
3. 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.
4. 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.
5. Self-reported body weight fluctuation of ≤ 5.0% within 12 weeks prior to screening through diet and exercise control alone.
6. Willing and able to maintain a stable diet and exercise lifestyle throughout the study period.
7. SAD cohort: body weight ≥ 50 kg, BMI 19.0-28.0 kg/m² (inclusive). MAD cohort: BMI 28.0-40.0 kg/m² (inclusive).

Exclusion Criteria:

1. 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.
2. Clinically significant abnormalities in vital signs, physical examination, laboratory tests, or 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.
3. 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.
4. 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.
5. 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).
6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2), or screening calcitonin level ≥ 50 ng/L.
7. 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).
8. History of diabetes mellitus (type 1, type 2, or rare forms of diabetes).
9. 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.
10. Use of any medication or treatment known to cause significant weight gain or weight loss within 3 months prior to screening.
11. Any other condition that, in the investigator's opinion, would make the participant unsuitable for enrollment in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-20136-2; Subcutaneous injection once，Subcutaneous injection three times	Drug: HS-20136-2; Single-dose pen of HS-20136-2 injection solution; Drug: HS-20136-2; multi-dose pen of HS-20136-2 injection solution
Placebo Comparator: placebo; Subcutaneous injection once，Subcutaneous injection three times	Drug: Placebo; Single-dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve (AUC) of HS-20136-2	AUC of HS-20136-2 after single subcutaneous injection	Start of Treatment to end of study (approximately 57 days)
AUC of HS-20136-2	AUC of HS-20136-2 after multiple subcutaneous injection	Start of Treatment to end of study (approximately 112 days)
Immunogenicity	anti- HS-20136-2 antibody	Start of Treatment to end of study (approximately 112 days)
body weight change	body weight change from baseline	Start of Treatment to end of study (approximately 112 days)

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): September 22, 2026
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2027

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: obesity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: HS-20136-2-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No