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- Sperimentazione clinica NCT07924761
A Study to Investigate the Effect of Injection Site and Ethnicity on KAI-4729 Pharmacokinetics in Non-Asian and Asian Participants Living With Obesity or Overweight
A Phase 1, Randomized, Open-Label, Single-Dose Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-4729 Subcutaneous Injection and Pharmacokinetics of KAI-4729 in Non-Asian and Asian Participants Living With Obesity or Overweight
The main objectives of this study are to assess the relative bioavailability of KAI-4729 subcutaneous (SC) injection in the upper arm and thigh compared with the abdomen and to measure the pharmacokinetics of KAI-4729 in plasma following a single SC dose in healthy non-Asian and Asian participants.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Kailera Therapeutics, Inc.
- Numero di telefono: 1-781-317-0291
- Email: info-clinicalstudies@kailera.com
Luoghi di studio
-
-
California
-
Anaheim, California, Stati Uniti, 92801
- Kailera Clinical Site
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Key Inclusion Criteria:
- Have a body mass index (BMI) ≥25 and ≤40 kilograms per square meter at screening (Days -28 to -2) and on Day -1 of the first Treatment Period
- Non-Asian Participants Only: Be of non-Asian descent and not identify as being of East Asian origin
- Asian Participants Only: Be of Asian descent, identify as being of East Asian origin, and have both parents and both sets of grandparents born in East Asia and of East Asian descent
- Medically healthy
Key Exclusion Criteria:
- Have estimated glomerular filtration rate <60 milliliters/minute/1.73 square meters at screening (Days -28 to -2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration calculation.
- Have hemoglobin A1c test result ≥6.5% or blood glucose ≥126 milligrams/deciliter (≥7 millimoles/liter) at screening (Days -28 to -2).
- Have a history of, or positive test results at screening (Days -28 to -2) for, human immunodeficiency virus (HIV), hepatitis B surface antigen, or active hepatitis C virus infection.
- Have positive drugs of abuse or alcohol test results at screening (Days -28 to -2) or on Day -1 of each Treatment Period.
- Be pregnant or planning to be pregnant and/or breastfeeding or planning to breastfeed during the study and within 5 half-lives of the study drug (25 days) following the last study treatment dose.
- Have any history of malignant disease, including in situ cervical or prostate cancer, within the 5 years prior to informed consent (excludes basal or squamous cell carcinoma that was successfully treated).
- Have history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the 3 months prior to informed consent determined by the Investigator (or delegate) to be clinically relevant.
- Have known hypersensitivity to the study drug; glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide, and/or glucagon receptor agonist therapies; or any of the study drug ingredients.
- Have any other conditions or received prior therapy that, in the opinion of the Investigator (or delegate), 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Upper Arm Injection Site
Participants will receive KAI-4729 as a single SC injection into the upper arm on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Sperimentale: Abdomen Injection Site
Participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Sperimentale: Thigh Injection Site
Participants will receive KAI-4729 as a single SC injection into the thigh on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Sperimentale: Abdomen Injection Site (Asian Participants)
Asian participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of Treatment Period 1. |
SC injection |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Lasso di tempo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Lasso di tempo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Lasso di tempo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Cmax of KAI-4729 in Healthy Non-Asian and Asian Participants
Lasso di tempo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
|
AUC0-t of KAI-4729 in Healthy Non-Asian and Asian Participants
Lasso di tempo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
|
AUC0-inf of KAI-4729 in Healthy Non-Asian and Asian Participants
Lasso di tempo: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Lasso di tempo: Day 1 to Day 99
|
Day 1 to Day 99
|
|
Number of Participants Who Experience a Serious Adverse Event (SAE)
Lasso di tempo: Day 1 to Day 99
|
Day 1 to Day 99
|
|
Number of Participants Who Experience Antidrug Antibodies (ADAs) to KAI-4729
Lasso di tempo: Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose
|
Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Medical Director, Kailera Therapeutics, Inc.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K4729-1115
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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