A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects

Sponsor
Sunshine Lake Pharma Co., Ltd.
Study ID
NCT05459285
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 14028 injection — BIOLOGICAL
    14028 injection, single dose, s.c. injection
  • dulaglutide injection — BIOLOGICAL
    dulaglutide injection(TRULICITY®), single dose, s.c. injection

Study Details

To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between 14028 Injection and TRULICITY® in Healthy Subjects

Key Dates

Start date
May 31, 2022
Status verified
Aug 2022
Primary completion
Jul 2, 2022
Completion
Jul 8, 2022

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 14028 injection
    Subjects receive 14028 injection in the study, 0.75mg, once
  • Active Comparator: dulaglutide injection (TRULICITY®)
    Subjects receive dulaglutide injection (TRULICITY®) in the study, 0.75mg, once

Primary Outcome Measure

Maximum (peak) plasma drug concentration(Cmax) [ Time Frame: 0 hour (pre-dose,within 30mins) to 384 hours after administration ]

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