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

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

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 Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: THDB0206 injection-Upper arm; Drug: THDB0206 Injection-Abdomen; Drug: THDB0206 Injection-Thigh

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan, China
    • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THDB0206 injection-Upper Arm	Drug: THDB0206 injection-Upper arm; Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm.
Experimental: THDB0206 injection-Abdomen	Drug: THDB0206 Injection-Abdomen; Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen.
Experimental: THDB0206 injection-Thigh	Drug: THDB0206 Injection-Thigh; Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCLisp(0-inf)	Area under the insulin lispro plasma concentration-time curve from zero to infinity	From 0 to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Lisp)	The maximum plasma concentration of insulin lispro observed	From 0 to 8 hours
AUCLisp	Area under the insulin lispro plasma concentration-time curve	From 0 to 8 hours
tmax(Lisp)	Time to reach the maximum insulin lispro plasma concentration	From 0 to 8 hours
t1/2	Terminal half-life	From 0 to 8 hours
Vz/F	Apparent volume of distribution	From 0 to 8 hours
AUCGIR	Area under the glucose infusion rate-time curve	From 0 to 8 hours
GIRtot	Total glucose infusion during clamping	From 0 to 8 hours
GIRmax	Maximum glucose infusion rate	From 0 to 8 hours
tGIRmax	Time to reach the maximum glucose infusion rate	From 0 to 8 hours
Number of participants with abnormal clinical laboratory findings (haematology, biochemistry and urinalysis)		From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal 12-lead ECG parameters (PR, QR, QRS intervals and QTc)		From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal vital signs (body temperature, supine blood pressure and pulse rate)		From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal physical examination (general condition, head and five sense organs, neck, chest, abdomen, spine and limbs, nervous system)		From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with hypoglycemia events in each treatment arm		From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with AE and SAE		From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
CL/F	CL/F	From 0 to 8 hours
Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration, and others)		From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)

Collaborators and Investigators

• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Actual): December 2, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: THDB0206L03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No