CompletedPhase 1

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

China27 participantsStarted 2024-04-17

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

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Inclusion criteria

✓. Aged ≥18 and ≤40 years at screening.
✓. 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.
✓. 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.
✓. Glycated hemoglobin (HbA1c) ≤6.1% at screening.

Exclusion criteria

✕. Known or suspected hypersensitivity to the investigational product or related products, or a history of severe allergies to drugs or foods.
✕. Insulin release test at screening considered abnormal with clinical significance in the investigator's judgment.
✕. Increased risk of thromboembolism, such as known coagulation disorders, (family) history of thrombosis, or relevant arrhythmias (e.g., paroxysmal atrial fibrillation).
✕. 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).
✕. 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.
✕. Donation of blood or plasma within the past month, or donation of more than 300 mL of blood within 3 months prior to screening.

What they're measuring

AUCLisp(0-inf)

Timeframe: From 0 to 8 hours

Trial details

NCT IDNCT07257627

SponsorTonghua Dongbao Pharmaceutical Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-02

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