A Single Ascending Dose Study of SYH2082 Injection in Healthy Participants

NCT07532655 | Not Yet Recruiting Phase 1

• 1 other identifier: SYH2082-002
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and tolerability of single dose of SYH2082 Injection in healthy participants.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events as a measure of safety and tolerability of SYH2082

  Screening period up to day 57

Secondary Outcomes (15)

• Maximum plasma concentration (Cmax)

  Pre-dose at day 1 to day 57

• Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)

  Pre-dose at day 1 to day 57

• Area under the concentration time curve from time 0 to infinity (AUCinf)

  Pre-dose at day 1 to day 57

• Time to maximum concentration (Tmax)

  Pre-dose at day 1 to day 57

• Elimination half-life (t1/2)

  Pre-dose at day 1 to day 57

Study Arms (2)

SYH2082 Injection

EXPERIMENTAL

Single-ascending dose

Drug: SYH2082 Injection

Placebo

PLACEBO COMPARATOR

Single dose

Drug: Placebo

Interventions

SYH2082 Injection DRUG

A subcutaneous injection in the abdomen of the corresponding dose of SYH2082 Injection according to the assigned dose cohort.

SYH2082 Injection

Placebo DRUG

A subcutaneous injection in the abdomen of the corresponding dose of Placebo according to the assigned dose cohort.

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:

• Fully understands the content, procedures, and possible adverse reactions of the study, and voluntarily signs the ICF before the study;
• At screening, age 18-65 years (inclusive, at the time of signing the ICF), male or female;
• At screening, body weight ≥50 kg for males and ≥45 kg for females; body mass index (BMI) between 22.0 and 40.0 kg/m2 (inclusive);
• Body weight change ≤5% within 3 months prior to screening (including the screening period);
• From the time of signing the ICF until 6 months after the last dose, the participant (including their partner) has no plans for childbirth and agrees to use highly effective contraceptive measures.

You may not qualify if:

• Known or suspected allergy to glucagon-like peptide-1 (GLP-1) or Glucose dependent insulinotropic polypeptide (GIP) receptor agonists or any component of the investigational product; or has an allergic constitution (allergic to multiple drugs and foods);
• Abnormal results in vital signs, physical examination, laboratory tests, and ECG that are judged by the investigator to be clinically significant within the screening period. Specifically, the following conditions are not excluded:
• Systolic blood pressure (SBP) \< 160 mmHg, diastolic blood pressure (DBP) \< 100 mmHg;
• Fasting TG ≤ 5.6 mmol/L, fasting TC ≤ 7.5 mmol/L, fasting LDL-C ≤ 5 mmol/L, and abnormal fasting HDL-C;
• Alanine aminotransferase (ALT) \< 2 × ULN, aspartate aminotransferase (AST) \< 2 × ULN, gamma-glutamyl transferase (GGT) \< 2.5 × ULN, and total bilirubin (TBIL) \< 1.5 × ULN. Participants with values outside the normal range may be included if the abnormality is deemed benign by the investigator (e.g., Gilbert's syndrome);
• History or laboratory evidence of diabetes mellitus (type 2, type 1, or other forms of diabetes), including fasting glucose of ≥126 mg/dL (7.0 mmol/L) and/or HbA1c ≥ 6.5% within the screening period;
• With any previous episode of hypoglycemia or with screening fasting glucose \< 3.9mmol/L (even on a single sample);
• With obesity due to identifiable endocrinologic, genetic or syndromic causes;
• Meets any of the following criteria within the screening period:
• Calcitonin ≥25 ng/L;
• Estimated glomerular filtration rate (eGFR) \<80 mL/min/1.73m2
• Thyroid-stimulating hormone (TSH) outside the normal reference range;
• Fasting serum amylase and/or lipase \>1.5× ULN.
• At screening, has a prolonged QT/QTc interval (QTcF \>450 ms for males and QTcF\>470 ms for females), or a history of risk factors for Torsades de Pointes (e.g., cardiac failure/cardiomyopathy or a family history of long QT syndrome), or is currently taking concomitant medications that prolong the QT/QTc interval;
• Positive for any of the following: Hepatitis B surface antigen, Hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis serology;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.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

Model Details: Interventional

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 16, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): February 9, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04