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

Kailera

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: KAI-9531

Study type: Interventional

Funder types: Industry

Identifiers

NCT07044401

K9531-1102

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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51 participants in 3 patient groups

KAI-9531: Abdomen Injection Site

Experimental group

Description:

Participants will receive KAI-9531 as a SC injection into the abdomen on Day 1 of either Treatment Period 1, 2 or 3.

Treatment:

Drug: KAI-9531

KAI-9531: Thigh Injection Site

Experimental group

Description:

Participants will receive KAI-9531 as a SC injection into the thigh on Day 1 of either Treatment Period 1, 2 or 3.

Treatment:

Drug: KAI-9531

KAI-9531: Upper Arm Injection Site

Experimental group

Description:

Participants will receive KAI-9531 as a SC injection into the upper arm on Day 1 of either Treatment Period 1, 2 or 3.

Treatment:

Drug: KAI-9531