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

Not Applicable

Active, not recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: KAI-9531

• Registration Number: NCT07044401
• Lead Sponsor: Kailera

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Study First Posted: 2025-07-01
• Study Start: 2025-07-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-21
• Last Update Posted: 2025-08-22
• Primary Completion: 2025-11-13
• Study Completion: 2025-11-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Body mass index (BMI) ≥ 25.0 and ≤ 40.0 kilograms per square meter (kg/m^2), with a body weight ≤ 120 kg.
• Medically healthy.

Exclusion Criteria

• Known hypersensitivity to the study drug or any of the study drug ingredients.
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder.
• Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
• Estimated glomerular filtration rate (eGFR) <60 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• Glycosylated hemoglobin (HbA1c) test result ≥6.5%.
• A history of or positive test results at the Screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody (HCVab) with HCV ribonucleic acid (RNA) confirmation if positive.
• Positive drugs of abuse or alcohol test results.
• Participation in another clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer).
• Any other condition or prior therapy that would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience Antidrug Antibodies to KAI-9531	Day 1 to Day 113
Number of Participants Who Experience a Serious Adverse Event (SAE)	Day 1 to Day 113
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)	Day 1 to Day 113

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States