Healthy Volunteers
Conditions
Keywords
Overweight, Obesity, KAI-9531
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.
Interventions
DRUGKAI-9531
SC Injection.
Sponsors
Kailera
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) | 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 Antidrug Antibodies to KAI-9531 | Day 1 to Day 113 |
Countries
United States
Outcome results
None listed