- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Kailera Therapeutics, Inc.
- Puhelinnumero: 1-781-317-0291
- Sähköposti: info-clinicalstudies@kailera.com
Opiskelupaikat
-
-
California
-
Anaheim, California, Yhdysvallat, 92801
- Kailera Clinical Site
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
|
Kokeellinen: 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 |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Aikaikkuna: Day 1 to Day 99
|
Day 1 to Day 99
|
|
Number of Participants Who Experience a Serious Adverse Event (SAE)
Aikaikkuna: Day 1 to Day 99
|
Day 1 to Day 99
|
|
Number of Participants Who Experience Antidrug Antibodies (ADAs) to KAI-4729
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Medical Director, Kailera Therapeutics, Inc.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- K4729-1115
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .