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

NCT07044401 | Completed Phase 1 FDA Drug

• 1 other identifier: K9531-1102
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Overweight; Obesity; KAI-9531

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (3)

KAI-9531: Abdomen Injection Site

EXPERIMENTAL

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

Drug: KAI-9531

KAI-9531: Thigh Injection Site

EXPERIMENTAL

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

Drug: KAI-9531

KAI-9531: Upper Arm Injection Site

EXPERIMENTAL

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

Drug: KAI-9531

Interventions

KAI-9531 DRUG

SC Injection.

KAI-9531: Abdomen Injection Site; KAI-9531: Thigh Injection Site; KAI-9531: Upper Arm Injection Site

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Kailera: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: July 14, 2025
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)