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

NCT07257627 | Completed Phase 1

• 1 other identifier: THDB0206L03
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• AUCLisp(0-inf)

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

  From 0 to 8 hours

Secondary Outcomes (17)

• Cmax (Lisp)

  From 0 to 8 hours

• AUCLisp

  From 0 to 8 hours

• tmax(Lisp)

  From 0 to 8 hours

• t1/2

  From 0 to 8 hours

• CL/F

  From 0 to 8 hours

Study Arms (3)

THDB0206 injection-Upper Arm

EXPERIMENTAL

Drug: THDB0206 injection-Upper arm

THDB0206 injection-Abdomen

EXPERIMENTAL

Drug: THDB0206 Injection-Abdomen

THDB0206 injection-Thigh

EXPERIMENTAL

Drug: THDB0206 Injection-Thigh

Interventions

THDB0206 injection-Upper arm DRUG

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

THDB0206 injection-Upper Arm

THDB0206 Injection-Abdomen DRUG

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

THDB0206 injection-Abdomen

THDB0206 Injection-Thigh DRUG

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

THDB0206 injection-Thigh

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tonghua Dongbao Pharmaceutical Co.,Ltd: lead

Study Sites (1)

West China Hospital of Sichuan University

Sichuan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: April 17, 2024
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)