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

ConditionObesity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-20136-2

    Drug

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

  • Placebo

    Drug

    Single-dose of placebo

  • HS-20136-2

    Drug

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

  • placebo

    Drug

    multi-dose of placebo

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: HS-20136-2Experimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Adverse Events

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

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

Secondary outcomes

1

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

AUC of HS-20136-2 after single subcutaneous injection

Time frame
Start of Treatment to end of study (approximately 57 days)
2

AUC of HS-20136-2

AUC of HS-20136-2 after multiple subcutaneous injection

Time frame
Start of Treatment to end of study (approximately 112 days)
3

Immunogenicity

anti- HS-20136-2 antibody

Time frame
Start of Treatment to end of study (approximately 112 days)
4

body weight change

body weight change from baseline

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

Other outcomes

Sponsors and contacts

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