Comparative PK/PD of Single-Dose THDB0206 at Different Injection Sites

NCT ID: NCT07257627

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2024-12-02

Brief Summary

This open-label, randomized, three-period crossover, 8-hour hyperinsulinemic-euglycemic clamp study will compare the pharmacokinetic and pharmacodynamic profiles of THDB0206 after single subcutaneous administration at different injection sites in healthy Chinese adults.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

THDB0206 injection-Upper Arm

Group Type: EXPERIMENTAL

THDB0206 injection-Upper arm

Intervention Type: DRUG

Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm.

THDB0206 injection-Abdomen

Group Type: EXPERIMENTAL

THDB0206 Injection-Abdomen

Intervention Type: DRUG

Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen.

THDB0206 injection-Thigh

Group Type: EXPERIMENTAL

THDB0206 Injection-Thigh

Intervention Type: DRUG

Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh.

Interventions

THDB0206 injection-Upper arm

Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm.

Intervention Type: DRUG

THDB0206 Injection-Abdomen

Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen.

Intervention Type: DRUG

THDB0206 Injection-Thigh

Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18 and ≤40 years at screening.

2. Body mass index (BMI) ≥18 kg/m² and <25 kg/m² at screening; body weight ≥50 kg for males and ≥45 kg for females at screening.

3. At screening, 75 g oral glucose tolerance test (OGTT): fasting venous plasma glucose <6.1 mmol/L and 2-hour post-load venous plasma glucose <7.8 mmol/L.

4. Glycated hemoglobin (HbA1c) ≤6.1% at screening.

Exclusion Criteria

1. Known or suspected hypersensitivity to the investigational product or related products, or a history of severe allergies to drugs or foods.

2. Insulin release test at screening considered abnormal with clinical significance in the investigator's judgment.

3. Increased risk of thromboembolism, such as known coagulation disorders, (family) history of thrombosis, or relevant arrhythmias (e.g., paroxysmal atrial fibrillation).

4. In the investigator's judgment, a history of alcohol dependence or drug/chemical substance abuse; or positive results on drug screening/breath alcohol testing at screening; or alcohol consumption exceeding 21 units per week (male subjects) or 14 units per week (female subjects).

5. Subjects who smoked on average more than 5 cigarettes per day within 1 year prior to screening and are unwilling to abstain from smoking during the study.

6. Donation of blood or plasma within the past month, or donation of more than 300 mL of blood within 3 months prior to screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tonghua Dongbao Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital of Sichuan University

Sichuan, , China

Countries

China

Other Identifiers

THDB0206L03

Identifier Type: -

Identifier Source: org_study_id