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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

18. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BIIB144 Cohort 1
Participants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1.
Medicin: Placebo
Administreret IV
Medicin: BIIB144
Administered IV
Eksperimentel: BIIB144 Cohort 2
Participants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1.
Medicin: Placebo
Administreret IV
Medicin: BIIB144
Administered IV
Eksperimentel: BIIB144 Cohort 3
Participants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1.
Medicin: Placebo
Administreret IV
Medicin: BIIB144
Administered IV
Eksperimentel: BIIB144 Cohort 4
Participants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1.
Medicin: Placebo
Administreret IV
Medicin: BIIB144
Administered IV
Eksperimentel: BIIB144 Cohort 5
Participants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1.
Medicin: Placebo
Administreret IV
Medicin: BIIB144
Administered IV
Eksperimentel: BIIB144 Cohort 6
Participants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1.
Medicin: Placebo
Administreret IV
Medicin: BIIB144
Administered IV

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to Day 280
Up to Day 280

Sekundære resultatmål

Resultatmål
Tidsramme
Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) of BIIB144
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biogen

Efterforskere

  • Studieleder: Medical Director, Biogen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

7. juli 2026

Primær færdiggørelse (Anslået)

19. juni 2028

Studieafslutning (Anslået)

19. juni 2028

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

23. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 301HV101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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