A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Kailera
Study ID
NCT07044401
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main objective of the study is to assess the relative bioavailability of KAI-9531 subcutaneous (SC) injection in the upper arm and thigh compared to the abdomen.

Key Dates

Start date
Jul 14, 2025
Status verified
Dec 2025
Primary completion
Nov 13, 2025
Completion
Nov 13, 2025

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: KAI-9531: Abdomen Injection Site
    Participants will receive KAI-9531 as a SC injection into the abdomen on Day 1 of either Treatment Period 1, 2 or 3.
  • Experimental: KAI-9531: Thigh Injection Site
    Participants will receive KAI-9531 as a SC injection into the thigh on Day 1 of either Treatment Period 1, 2 or 3.
  • Experimental: KAI-9531: Upper Arm Injection Site
    Participants will receive KAI-9531 as a SC injection into the upper arm on Day 1 of either Treatment Period 1, 2 or 3.

Primary Outcome Measure

Maximum Observed Concentration (Cmax) of KAI-9531 [ Time Frame: Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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