A Study to Evaluate Safety, Tolerability and pK of Semaglutide ER Injectable Suspension in Healthy, Adult Human Subjects

Sponsor
Bostal Drug Delivery Co., Ltd
Study ID
NCT06422624
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of the trail is to evaluate the safety, tolerability and pharmacokinetics of a single escalated doses of semaglutide extended-release injectable suspension in healthy adult, human study participants under fasting condition.

Key Dates

Start date
Aug 31, 2024
Status verified
May 2024
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024

Study Design

Enrollment
14 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide ER Injectable Suspension, 1 mg
    Participants receive a single of semaglutide ER injectable suspension at a lower dose 1 mg for safety, tolerability and pharmacokinetics assessements
  • Experimental: Semaglutide ER Injectable Suspension, 4 mg
    Participants receive a single of semaglutide ER injectable suspension at a medium dose 4 mg for safety, tolerability and pharmacokinetics assessements
  • Experimental: Semaglutide ER Injectable Suspension, 8 mg
    Participants receive a single of semaglutide ER injectable suspension at a higher dose 8 mg for safety, tolerability and pharmacokinetics assessements

Primary Outcome Measure

Cmax [ Time Frame: From time zero up to the last time point with measurable concentration ]

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