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

Tonghua Dongbao Pharmaceutical Co.,Ltd27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

THDB0206 injection-Upper armDRUG

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

THDB0206 Injection-AbdomenDRUG

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

THDB0206 Injection-ThighDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

West China Hospital of Sichuan University

Sichuan, China

Outcomes

Primary Outcomes

AUCLisp(0-inf)

Area under the insulin lispro plasma concentration-time curve from zero to infinity

Time frame: From 0 to 8 hours

Secondary Outcomes

Cmax (Lisp)

The maximum plasma concentration of insulin lispro observed

Time frame: From 0 to 8 hours

AUCLisp

Area under the insulin lispro plasma concentration-time curve

Time frame: From 0 to 8 hours

tmax(Lisp)

Time to reach the maximum insulin lispro plasma concentration

Time frame: From 0 to 8 hours

t1/2

Terminal half-life

Time frame: From 0 to 8 hours

CL/F

Time frame: From 0 to 8 hours

Vz/F

Apparent volume of distribution

Time frame: From 0 to 8 hours

AUCGIR

Area under the glucose infusion rate-time curve

Time frame: From 0 to 8 hours

GIRtot

Total glucose infusion during clamping

Time frame: From 0 to 8 hours

GIRmax

Data from ClinicalTrials.gov

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