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Completed

NCT Number: NCT07044401

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KAI-9531

Drug

SC Injection.

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of KAI-9531

    Time frame: Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose

  2. Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-9531

    Time frame: Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose

  3. Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-9531

    Time frame: Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose

Secondary outcomes

  1. Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

    Time frame: Day 1 to Day 113

  2. Number of Participants Who Experience a Serious Adverse Event (SAE)

    Time frame: Day 1 to Day 113

  3. Number of Participants Who Experience Antidrug Antibodies to KAI-9531

    Time frame: Day 1 to Day 113

Sponsors and collaborators

Lead sponsor

Kailera

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-label, Single-Dose, Crossover Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-9531 Subcutaneous Injection in Participants With a Range of Body Mass Indices

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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