A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is Processed in the Body of Healthy Adult Participants Ages 18 to 55 Years Old as Compared to a Placebo
24 juillet 2026 mis à jour par: Biogen
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB144 in Healthy Adult Participants
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups.
The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug.
The main question researchers want to answer in this study is:
How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug.
Researchers will also learn more about:
- How the body processes BIIB144 compared to placebo.
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which eligible participants will check into their study research center.
- Participants will stay at their study research center for about 8 days. Afterwards, they will have up to 13 visits to their study research center.
- This will be a "dose escalation" study. In this kind of study, increasing amounts of study drug are given to different groups of participants. Usually, this is done until researchers find the highest dose that does not cause harmful effects. In this study, the number of dose groups and maximum dose are planned in advance. The dose escalation will stop once these planned groups are done or if safety concerns arise.
- There will be a total of 6 groups. In each group, participants will receive a single dose of either BIIB144 or the placebo through an intravenous (IV) needle.
- Throughout the study, participants will give blood and urine samples. Participants will also have physical exams and answer questions about how they are feeling.
- Each participant will be in the study for up to 44 weeks.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
The primary objective of this study is to evaluate the safety and tolerability of IV administered ascending single doses of BIIB144 compared with placebo in healthy adult participants.
The secondary objective is to characterize the pharmacokinetics (PK) of IV administered ascending single doses of BIIB144 in healthy adult participants.
Type d'étude
Interventionnel
Inscription (Estimé)
48
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: US Biogen Clinical Trial Center
- Numéro de téléphone: 866-633-4636
- E-mail: clinicaltrials@biogen.com
Sauvegarde des contacts de l'étude
- Nom: Global Biogen Clinical Trial Center
- E-mail: clinicaltrials@biogen.com
Lieux d'étude
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89113
- Recrutement
- Las Vegas Clinical Research Unit, PPD Development, LP
-
Contact:
- Numéro de téléphone: 702-963-1600
-
Chercheur principal:
- Aishwarya Vyas Lahar
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Key Inclusion Criteria:
- Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m^2), inclusive, at Screening.
- Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Key Exclusion Criteria:
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
- History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Day -1).
- History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- Any live or attenuated immunization or vaccination given within 14 days prior to Screening, between Screening and Day -1, or planned to be given during the study period.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: BIIB144 Cohort 1
Participants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1.
|
Administré IV
Administered IV
|
|
Expérimental: BIIB144 Cohort 2
Participants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administré IV
Administered IV
|
|
Expérimental: BIIB144 Cohort 3
Participants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administré IV
Administered IV
|
|
Expérimental: BIIB144 Cohort 4
Participants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administré IV
Administered IV
|
|
Expérimental: BIIB144 Cohort 5
Participants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administré IV
Administered IV
|
|
Expérimental: BIIB144 Cohort 6
Participants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1.
|
Administré IV
Administered IV
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Délai: Up to Day 280
|
Up to Day 280
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) of BIIB144
Délai: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of BIIB144
Délai: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Maximum Observed Serum Concentration (Cmax) of BIIB144
Délai: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Time to Maximum Observed Serum Concentration (Tmax) of BIIB144
Délai: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Terminal Elimination Half-Life (t½) of BIIB144
Délai: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Total Body Clearance (CL) of BIIB144
Délai: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
|
Volume of Distribution During the Terminal Elimination Phase (Vz) of BIIB144
Délai: Pre-dose and at multiple time points post-dose up to Day 280
|
Pre-dose and at multiple time points post-dose up to Day 280
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Biogen
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 juillet 2026
Achèvement primaire (Estimé)
19 juin 2028
Achèvement de l'étude (Estimé)
19 juin 2028
Dates d'inscription aux études
Première soumission
18 juin 2026
Première soumission répondant aux critères de contrôle qualité
18 juin 2026
Première publication (Réel)
23 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 301HV101
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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