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A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Doses of ABBV-1451 Infusions and Injections in Healthy Adult Participants

26. maj 2026 opdateret af: AbbVie

A First in Human, Single Ascending Dose Study of ABBV-1451 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Healthy Subjects and in Japanese and Han Chinese Healthy Subjects

The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in healthy adult volunteers.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Illinois
      • Grayslake, Illinois, Forenede Stater, 60030
        • Rekruttering
        • Acpru /Id# 282128

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

Inclusion Criteria:

  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
  • Applies to Part 2 only:

  • For Japanese participants:

    -- Participant must be first or second-generation Japanese of full Japanese parentage, residing outside of Japan. First generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. Participants must be in general good health.

  • For Han Chinese participants:

    • Participant must be first or second-generation Han Chinese of full Chinese parentage, residing outside of China. First generation participants will have been born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must be in general good health.

Exclusion Criteria:

  • History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
  • History of any clinically significant sensitivity or allergy to any medication or food.
  • History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part 1: Group 1
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.
Andet: Placebo
Infusion
Medicin: ABBV-1451
Injection
Medicin: ABBV-1451
Infusion
Andet: Placebo
Injection
Eksperimentel: Part 1: Group 2
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose B or placebo.
Andet: Placebo
Infusion
Medicin: ABBV-1451
Injection
Medicin: ABBV-1451
Infusion
Andet: Placebo
Injection
Eksperimentel: Part 1: Group 3
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.
Andet: Placebo
Infusion
Medicin: ABBV-1451
Injection
Medicin: ABBV-1451
Infusion
Andet: Placebo
Injection
Eksperimentel: Part 1: Group 4
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.
Andet: Placebo
Infusion
Medicin: ABBV-1451
Injection
Medicin: ABBV-1451
Infusion
Andet: Placebo
Injection
Eksperimentel: Part 1: Group 5
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.
Andet: Placebo
Infusion
Medicin: ABBV-1451
Injection
Medicin: ABBV-1451
Infusion
Andet: Placebo
Injection
Eksperimentel: Part 1: Group 6
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose TBD or placebo.
Andet: Placebo
Infusion
Medicin: ABBV-1451
Injection
Medicin: ABBV-1451
Infusion
Andet: Placebo
Injection
Eksperimentel: Part 2: Group 7
Japanese participants will receive a single dose of ABBV-1451 Dose C or placebo.
Andet: Placebo
Infusion
Medicin: ABBV-1451
Injection
Medicin: ABBV-1451
Infusion
Andet: Placebo
Injection
Eksperimentel: Part 2: Group 8
Han Chinese participants will receive a single dose of ABBV-1451 Dose C or placebo.
Andet: Placebo
Infusion
Medicin: ABBV-1451
Injection
Medicin: ABBV-1451
Infusion
Andet: Placebo
Injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Adverse Events (AEs)
Tidsramme: Up to Approximately Day 211
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to Approximately Day 211
Maximum Observed Plasma Concentration (Cmax) of ABBV-1451
Tidsramme: Up to Approximately Day 211
Cmax of ABBV-1451.
Up to Approximately Day 211
Time to Cmax (Tmax) of ABBV-1451
Tidsramme: Up to Approximately Day 211
Tmax of ABBV-1451.
Up to Approximately Day 211
Terminal Phase Elimination Rate Constant (β) of ABBV-1451
Tidsramme: Up to Approximately Day 211
β of ABBV-1451.
Up to Approximately Day 211
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451
Tidsramme: Up to Approximately Day 211
t1/2 of ABBV-1451.
Up to Approximately Day 211
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451
Tidsramme: Up to Approximately Day 211
AUCt of ABBV-1451.
Up to Approximately Day 211
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451
Tidsramme: Up to Approximately Day 211
AUCinf of ABBV-1451.
Up to Approximately Day 211

Samarbejdspartnere og efterforskere

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

Sponsor

AbbVie

Efterforskere

  • Studieleder: ABBVIE INC., AbbVie

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 (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • M26-116

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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