CompletedNCT07257627Updated Dec 2, 2025

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

A Phase 1 interventional study of THDB0206 injection-Upper arm and THDB0206 Injection-Abdomen in Healthy Participants, sponsored by Tonghua Dongbao Pharmaceutical Co.,Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Tonghua Dongbao Pharmaceutical Co.,Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 1 year 6 months after the study started (first participant enrolled Apr 2024, registered Nov 2025).

Phase: Phase 1
Study type: Interventional
Enrollment: 27
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study 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 studied

Healthy Participants

In context

Lead sponsor

Tonghua Dongbao Pharmaceutical Co.,Ltd is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 27 participants (actual)

Study arms

Experimental
THDB0206 injection-Upper Arm
Drug: THDB0206 injection-Upper arm
Experimental
THDB0206 injection-Abdomen
Drug: THDB0206 Injection-Abdomen
Experimental
THDB0206 injection-Thigh
Drug: THDB0206 Injection-Thigh

Interventions

DrugTHDB0206 injection-Upper arm
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm.
DrugTHDB0206 Injection-Abdomen
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen.
DrugTHDB0206 Injection-Thigh
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh.

What researchers measure

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
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
Maximum glucose infusion rate
Time frame: From 0 to 8 hours
tGIRmax
Time to reach the maximum glucose infusion rate
Time frame: From 0 to 8 hours
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)
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)
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)
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)
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)
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)
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)

Study locations

1 site

West China Hospital of Sichuan University
Sichuan, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07257627
Lead sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd
Responsible party: Sponsor
First posted: Dec 2, 2025
Start date: Apr 17, 2024
Primary completion: Dec 2, 2024
Completion: Dec 2, 2024
Last update: Dec 2, 2025

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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