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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

24 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

48

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89113
        • Rekrytering
        • Las Vegas Clinical Research Unit, PPD Development, LP
        • Kontakt:
          • Telefonnummer: 702-963-1600
        • Huvudutredare:
          • Aishwarya Vyas Lahar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Biogen

Utredare

  • Studierektor: Medical Director, Biogen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 juli 2026

Primärt slutförande (Beräknad)

19 juni 2028

Avslutad studie (Beräknad)

19 juni 2028

Studieregistreringsdatum

Först inskickad

18 juni 2026

Först inskickad som uppfyllde QC-kriterierna

18 juni 2026

Första postat (Faktisk)

23 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 301HV101

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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