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A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males
Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.
Summary
This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design. Insulin degludec and insulin icodec injection serves as the active control and is administered in an open-label manner. The study will be conducted across 6 cohorts, comprising 4 dose-escalation cohorts of UBT38006 (1, 3, 6, and 12 nmol/kg) , 1 active control cohort of insulin degludec (0.4 U/kg \[2.4 nmol/kg\]) and 1 active control cohort of insulin icodec (1.25 U/kg \[7.5 nmol/kg\]). The safety and tolerability (including local tolerability) as well as the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single subcutaneous doses of UBT38006 injection will be evaluated in healthy adult male participants. In Cohort 1 (1 nmol/kg), participants will be randomized in a 4:1 ratio to receive UBT38006 injection or placebo. In Cohorts 2-4 (3, 6, and 12 nmol/kg), participants will be randomized in an 8:2 ratio to receive the corresponding dose of UBT38006 injection or placebo. Participants in Cohort 5 (insulin degludec active control) will receive 0.4 U/kg (2.4 nmol/kg) insulin degludec injection. Participants in the insulin icodec cohort received a subcutaneous injection of insulin icodec at a dose of 1.25 U/kg(7.5 nmol/kg). Cohorts 1-4 will follow a double-blind design, while Cohort 5 and insulin icodec cohort will be open-label.
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of UBT38006 Injection in Healthy Adult Male Subjects
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2026-06-19
Completion Date
2026-10-25
Last Updated
2026-07-20
Healthy Volunteers
Yes
Conditions
Interventions
UBT38006
Ascending single doses - 4 dose levels
Placebo
Ascending single doses - 4 dose levels
Insulin Degludec Injection
single subcutaneous injection
Insulin Icodec Injection
single subcutaneous injection
Locations (1)
The Second Hospital of Anhui Medical University
Hefei, Anhui, China