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.
Study ID
NCT07630233
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • UBT38006 — DRUG
    Ascending single doses - 4 dose levels
  • Placebo — DRUG
    Ascending single doses - 4 dose levels
  • Insulin Degludec Injection — DRUG
    single subcutaneous injection

Study Details

This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design. Insulin degludec injection serves as the active control and is administered in an open-label manner. The study will be conducted across 5 cohorts, comprising 4 dose-escalation cohorts of UBT38006 (1, 3, 6, and 12 nmol/kg) and 1 active control cohort of insulin degludec (0.4 U/kg \[2.4 nmol/kg\]). 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 subjects. In Cohort 1 (1 nmol/kg), subjects will be randomized in a 4:1 ratio to receive either UBT38006 injection or placebo. In Cohorts 2-4 (3, 6, and 12 nmol/kg), subjects will be randomized in an 8:2 ratio to receive the corresponding dose of UBT38006 injection or placebo. Subjects in Cohort 5 (insulin degludec active control) will receive 0.4 U/kg (2.4 nmol/kg) insulin degludec injection. Cohorts 1-4 will follow a double-blind design, while Cohort 5 will be open-label.

Key Dates

Start date
Jun 19, 2026
Status verified
Jun 2026
Primary completion
Oct 25, 2026
Completion
Oct 25, 2026

Study Design

Enrollment
43 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UBT38006
    s.c, single dose
  • Placebo Comparator: Placebo
    s.c, single dose
  • Active Comparator: Active Control
    0.4U/kg Insulin Degludec Injection，single subcutaneous injection

Primary Outcome Measure

incidence of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), etc,.. [ Time Frame: Baseline to Day43 ]

Central Contacts

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