Recruiting
Phase 1

ABBV-1451

Sponsor:

AbbVie

Code:

NCT07570147

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

ABBV-1451

ABBV-1451

Placebo

Placebo

Study Details

Brief summary:

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.

Conditions

Healthy Volunteer

Study ID

NCT07570147

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Part 1: Group 1

Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.

experimental: Part 1: Group 2

Participants will receive either single ascending doses of ABBV-1451 until they reach Dose B or placebo.

experimental: Part 1: Group 3

Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.

experimental: Part 1: Group 4

Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo.

experimental: Part 1: Group 5

Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo.

experimental: Part 1: Group 6

Participants will receive either single ascending doses of ABBV-1451 until they reach Dose TBD or placebo.

experimental: Part 2: Group 7

Japanese participants will receive a single dose of ABBV-1451 Dose C or placebo.

experimental: Part 2: Group 8

Han Chinese participants will receive a single dose of ABBV-1451 Dose C or placebo.

Interventions

ABBV-1451

Injection

ABBV-1451

Infusion

Placebo

Injection

Placebo

Infusion

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Acpru /Id# 282128

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • Healthy Volunteer
  • ABBV-1451

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-05-28.