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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Other: Placebo; Drug: ABBV-1451; Drug: ABBV-1451; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Recruiting
      • Acpru /Id# 282128

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	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	Cmax of ABBV-1451.	Up to Approximately Day 211
Time to Cmax (Tmax) of ABBV-1451	Tmax of ABBV-1451.	Up to Approximately Day 211
Terminal Phase Elimination Rate Constant (β) of ABBV-1451	β of ABBV-1451.	Up to Approximately Day 211
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451	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	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	AUCinf of ABBV-1451.	Up to Approximately Day 211

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; ABBV-1451
• Other Study ID Numbers: M26-116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No