A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous or Intravenous Doses of ABBV-701 in Healthy Adult Western and Asian Participants

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: ABBV-701

Study type: Interventional

Funder types: Industry

Identifiers

NCT06895343

M25-491

Details and patient eligibility

About

The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single ascending doses of ABBV-701 in healthy adult western and Asian participants.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight is ≥ 35 kg and BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal.
• 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
• Part 2 and Part 4 only:

For Japanese Participants:

--Participant must be first or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

Han Chinese Participants:

--Participant must be first or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.

Exclusion criteria

• History of any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 12 patient groups

Part 1: Group 1 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose A or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 1: Group 2 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose B or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 1: Group 3 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose C or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 1: Group 4 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose D or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 1: Group 5 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose E or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 2: Group 6 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose E or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 2: Group 7 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose E or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 3: Group 8 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose C or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 3: Group 9 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose E or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 3: Group 10 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose F or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 4: Group 11 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose F or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701

Part 4: Group 12 ABBV-701 or Placebo

Experimental group

Description:

Participants will receive a single dose of either ABBV-701 Dose F or placebo.

Treatment:

Drug: Placebo

Drug: ABBV-701

Drug: Placebo

Drug: ABBV-701