Uno studio sul Remternetug (LY3372993) in partecipanti cinesi sani
Uno studio per valutare la sicurezza, la tollerabilità e la farmacocinetica di una singola dose di Remternetug in partecipanti cinesi sani
The study will evaluate the safety and tolerability of remternetug when given subcutaneously (SC) (under the skin) to healthy Chinese participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to 25 weeks, including screening period.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Beijing, Cina, 100053
- Xuanwu Hospital Capital Medical University
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Xuhui District, Cina, 20031
- Shanghai Xuhui Central Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and Magnetic resonance imaging (MRI).
- Participants must be native Chinese. To qualify as Chinese for this study, the participant, the participant's biological parents, and all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
- Have clinical laboratory test results within normal reference ranges for the population or study site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- Have a body mass index within the range 18.0 to 28.0 kilograms per square meter (kg/m²), inclusive.
- Are individuals Assigned Male at Birth (AMAB) or individuals Assigned Female at Birth (AFAB) who are individuals not of childbearing potential (INOCBP). Individual of childbearing potential (IOCBP) are excluded from the trial.
Exclusion Criteria:
- Are women who are lactating.
- Have known allergies to remternetug, related compounds, including donanemab, or any components of the formulation.
- Have history of allergies to medications for the emergency treatment of systemic hypersensitivity reactions, including anaphylaxis or infusion reactions (for example, epinephrine, diphenhydramine).
- Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
- Have an abnormal blood pressure or pulse rate as determined by the investigator, or a preexisting history of hypertension.
- Have a history or presence of significant psychiatric disorders.
- Have a brain MRI that demonstrates any clinically significant findings that in the opinion of the investigator may impact the participant's ability to safely participate in the study.
- Have a family history of early onset Alzheimer's disease (AD) (AD diagnosed prior to 65 years of age).
- Have a history or presence of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis.
- Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency.
- Have a history or presence of serious or unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, hematologic disease, or neurological disorders and other conditions that, in the investigator's opinion, could significantly alter the absorption, metabolism, or elimination of drugs; interfere with the analyses in this study; increase risk for study intervention administration; or result in a participant's life expectancy of less than 24 months.
- Have significant neurological disease affecting the central nervous system that may affect the participant's ability to complete the study, including but not limited to dementias, serious infection of the brain, Parkinson's disease, multiple concussions, intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, stroke, unprovoked seizure, epilepsy, or recurrent seizures (except febrile childhood seizures).
- Have donated blood of more than 400 milliliter (mL) within the previous 4 weeks of study screening, or plan for blood donation during the study period.
- Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Have had significant medical history of dizziness, syncope, or vasovagal attacks within the past 3 years.
- Have used or intend to use over-the-counter, prescription, or Chinese traditional medicines and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to dosing. Vitamins and mineral supplements not providing more than 100% of the recommended daily amount and thyroid hormone replacement are allowed.
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
- Have a positive Hepatitis C virus (HCV) antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV ribonucleic acid (RNA) test is negative.
- Show evidence of hepatitis B or positive hepatitis B surface antigen. Other Exclusion Criteria
- Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females; 1 unit = 12 ounce (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits.
- Are unwilling to stop alcohol consumption for 48 hours prior to admission to the study site or outpatient visits.
- Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes, are unwilling to refrain from smoking for approximately 1 hour prior to each ECG and vital sign measurement during the study, or are unable to abide by CRU smoking restrictions.
- Have Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) greater than or equal to 1.5× Upper Limit of Normal (ULN) at screening.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Remternetug
Remternetug will be administered subcutaneously (SC) |
Administered SC
Altri nomi:
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Comparatore placebo: Placebo
Placebo will be administered Subcutaneously (SC) |
Administered SC |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Numero di partecipanti con uno o più eventi avversi gravi (SAE) considerati dallo sperimentatore correlati alla somministrazione del farmaco in studio
Lasso di tempo: Dal basale fino al completamento dello studio fino a 25 settimane
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Dal basale fino al completamento dello studio fino a 25 settimane
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Farmacocinetica (PK): Concentrazione massima osservata del farmaco (Cmax) di Remternetug
Lasso di tempo: Dal Giorno 1 al Giorno 5
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Dal Giorno 1 al Giorno 5
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PK: Area Sotto la Curva Concentrazione-Tempo (AUC) di Remternetug
Lasso di tempo: Dal Giorno 1 al Giorno 5
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Dal Giorno 1 al Giorno 5
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 18470
- J1G-GH-LAKE (Altro identificatore: Eli Lilly and Company)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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