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

NCT07570147 | Not Yet Recruiting Phase 1

• 1 other identifier: M26-116
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy Volunteer; ABBV-1451

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (8)

Part 1: Group 1

EXPERIMENTAL

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

Drug: ABBV-1451; Other: Placebo

Part 1: Group 2

EXPERIMENTAL

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

Drug: ABBV-1451; Other: Placebo

Part 1: Group 3

EXPERIMENTAL

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

Drug: ABBV-1451; Other: Placebo

Part 1: Group 4

EXPERIMENTAL

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

Drug: ABBV-1451; Other: Placebo

Part 1: Group 5

EXPERIMENTAL

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

Drug: ABBV-1451; Other: Placebo

Part 1: Group 6

EXPERIMENTAL

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

Drug: ABBV-1451; Other: Placebo

Part 2: Group 7

EXPERIMENTAL

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

Drug: ABBV-1451; Other: Placebo

Part 2: Group 8

EXPERIMENTAL

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

Drug: ABBV-1451; Other: Placebo

Interventions

ABBV-1451 DRUG

Injection

Part 1: Group 1; Part 1: Group 2; Part 2: Group 8

Placebo OTHER

Injection

Part 1: Group 1; Part 1: Group 2; Part 2: Group 8

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 282128

Grayslake, Illinois, 60030, United States

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)