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Completed

NCT Number: NCT07257627

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital of Sichuan University

Sichuan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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-Abdomen

Drug

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

THDB0206 Injection-Thigh

Drug

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

Primary outcomes

  1. AUCLisp(0-inf)

    Time frame: From 0 to 8 hours

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

Secondary outcomes

  1. Cmax (Lisp)

    Time frame: From 0 to 8 hours

    The maximum plasma concentration of insulin lispro observed

  2. AUCLisp

    Time frame: From 0 to 8 hours

    Area under the insulin lispro plasma concentration-time curve

  3. tmax(Lisp)

    Time frame: From 0 to 8 hours

    Time to reach the maximum insulin lispro plasma concentration

  4. t1/2

    Time frame: From 0 to 8 hours

    Terminal half-life

  5. CL/F

    Time frame: From 0 to 8 hours

    CL/F

  6. Vz/F

    Time frame: From 0 to 8 hours

    Apparent volume of distribution

  7. AUCGIR

    Time frame: From 0 to 8 hours

    Area under the glucose infusion rate-time curve

  8. GIRtot

    Time frame: From 0 to 8 hours

    Total glucose infusion during clamping

  9. GIRmax

    Time frame: From 0 to 8 hours

    Maximum glucose infusion rate

  10. tGIRmax

    Time frame: From 0 to 8 hours

    Time to reach the maximum glucose infusion rate

  11. Number of participants with abnormal clinical laboratory findings (haematology, biochemistry and urinalysis)

    Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)

  12. Number of participants with abnormal 12-lead ECG parameters (PR, QR, QRS intervals and QTc)

    Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)

  13. Number of participants with abnormal vital signs (body temperature, supine blood pressure and pulse rate)

    Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)

  14. Number of participants with abnormal physical examination (general condition, head and five sense organs, neck, chest, abdomen, spine and limbs, nervous system)

    Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)

  15. Number of participants with hypoglycemia events in each treatment arm

    Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)

  16. Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration, and others)

    Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)

  17. Number of participants with AE and SAE

    Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)

Sponsors and collaborators

Lead sponsor

Tonghua Dongbao Pharmaceutical Co.,Ltd

Industry

Registry information

Official study title

An Open-Label, Randomized, Three-Period Crossover Study Comparing the Pharmacokinetics and Pharmacodynamics of Single-Dose THDB0206 Injection at Different Injection Sites in Healthy Chinese Adults

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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