Study S003232

A Phase 1, Randomized, Open-label, Single-Dose, Crossover Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-9531 Subcutaneous Injection in Participants With a Range of Body Mass Indices

ClinicalTrials.gov record

Registration

Registration: NCT07044401
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 51
Start: 2025-07-14
Primary completion: 2025-11-13
Lead sponsor: Kailera
Conditions: Healthy Volunteers
Interventions: DRUG:KAI-9531
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Maximum Observed Concentration (Cmax) of KAI-9531 [Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose]
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-9531 [Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose]
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-9531 [Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose]

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