West China Hospital of Sichuan University
Sichuan, China
NCT Number: NCT07257627
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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Notify Me18 year–40 year
All sexes
Interventional
Phase 1
Sichuan, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm.
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen.
Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh.
Time frame: From 0 to 8 hours
Area under the insulin lispro plasma concentration-time curve from zero to infinity
Time frame: From 0 to 8 hours
The maximum plasma concentration of insulin lispro observed
Time frame: From 0 to 8 hours
Area under the insulin lispro plasma concentration-time curve
Time frame: From 0 to 8 hours
Time to reach the maximum insulin lispro plasma concentration
Time frame: From 0 to 8 hours
Terminal half-life
Time frame: From 0 to 8 hours
CL/F
Time frame: From 0 to 8 hours
Apparent volume of distribution
Time frame: From 0 to 8 hours
Area under the glucose infusion rate-time curve
Time frame: From 0 to 8 hours
Total glucose infusion during clamping
Time frame: From 0 to 8 hours
Maximum glucose infusion rate
Time frame: From 0 to 8 hours
Time to reach the maximum glucose infusion rate
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Tonghua Dongbao Pharmaceutical Co.,Ltd
Industry
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
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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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