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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Other: Placebo; Drug: ABBV-1451

Study type: Interventional

Funder types: Industry

Identifiers

NCT07570147

M26-116

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 8 patient groups

Part 1: Group 1

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: ABBV-1451

Drug: ABBV-1451

Other: Placebo

Part 1: Group 2

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: ABBV-1451

Drug: ABBV-1451

Other: Placebo

Part 1: Group 3

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: ABBV-1451

Drug: ABBV-1451

Other: Placebo

Part 1: Group 4

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: ABBV-1451

Drug: ABBV-1451

Other: Placebo

Part 1: Group 5

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: ABBV-1451

Drug: ABBV-1451

Other: Placebo

Part 1: Group 6

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: ABBV-1451

Drug: ABBV-1451

Other: Placebo

Part 2: Group 7

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: ABBV-1451

Drug: ABBV-1451

Other: Placebo

Part 2: Group 8

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: ABBV-1451

Drug: ABBV-1451

Other: Placebo