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Recruiting NCT07570147

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

Phase I Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABBV-1451, ABBV-1451, Placebo, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug ABBV-1451
    Injection
  • Drug ABBV-1451
    Infusion
  • Other Placebo
    Injection
  • Other Placebo
    Infusion

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately Day 211]
  • Maximum Observed Plasma Concentration (Cmax) of ABBV-1451 [Time frame: Up to Approximately Day 211]
  • Time to Cmax (Tmax) of ABBV-1451 [Time frame: Up to Approximately Day 211]
  • Terminal Phase Elimination Rate Constant (β) of ABBV-1451 [Time frame: Up to Approximately Day 211]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451 [Time frame: 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 [Time frame: Up to Approximately Day 211]
  • Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451 [Time frame: Up to Approximately Day 211]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Acpru /Id# 282128 — Grayslake

Identifiers

NCT: NCT07570147 · M26-116

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗