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

Tonghua Dongbao Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: THDB0206 injection-Upper arm; Drug: THDB0206 Injection-Thigh; Drug: THDB0206 Injection-Abdomen

Study type: Interventional

Funder types: Industry

Identifiers

NCT07257627

THDB0206L03

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

THDB0206 injection-Upper Arm

Experimental group

Treatment:

Drug: THDB0206 injection-Upper arm

THDB0206 injection-Abdomen

Experimental group

Treatment:

Drug: THDB0206 Injection-Abdomen

THDB0206 injection-Thigh

Experimental group

Treatment:

Drug: THDB0206 Injection-Thigh