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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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 facts

Study ID

NCT07044401

Run by

Kailera

People needed

51

Starts

2025-07-14

Expected to finish

2025-11-13

Last updated by the study team

2025-12-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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