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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

NCT ID: NCT06895343

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-03

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1: Group 1 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

Subcutaneous

Placebo

Intervention Type DRUG

Subcutaneous

Part 1: Group 2 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

Subcutaneous

Placebo

Intervention Type DRUG

Subcutaneous

Part 1: Group 3 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

Subcutaneous

Placebo

Intervention Type DRUG

Subcutaneous

Part 1: Group 4 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

Subcutaneous

Placebo

Intervention Type DRUG

Subcutaneous

Part 1: Group 5 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

Subcutaneous

Placebo

Intervention Type DRUG

Subcutaneous

Part 2: Group 6 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

Subcutaneous

Placebo

Intervention Type DRUG

Subcutaneous

Part 2: Group 7 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

Subcutaneous

Placebo

Intervention Type DRUG

Subcutaneous

Part 3: Group 8 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

IV Infusion

Placebo

Intervention Type DRUG

IV infusion

Part 3: Group 9 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

IV Infusion

Placebo

Intervention Type DRUG

IV infusion

Part 3: Group 10 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

IV Infusion

Placebo

Intervention Type DRUG

IV infusion

Part 4: Group 11 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

IV Infusion

Placebo

Intervention Type DRUG

IV infusion

Part 4: Group 12 ABBV-701 or Placebo

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

Group Type EXPERIMENTAL

ABBV-701

Intervention Type DRUG

IV Infusion

Placebo

Intervention Type DRUG

IV infusion

Interventions

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ABBV-701

Subcutaneous

Intervention Type DRUG

Placebo

Subcutaneous

Intervention Type DRUG

ABBV-701

IV Infusion

Intervention Type DRUG

Placebo

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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CenExel ACT- Anaheim Clinical Trials /ID# 278431

Anaheim, California, United States

Site Status RECRUITING

Acpru /Id# 273354

Grayslake, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

[email protected]
844-663-3742

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M25-491

Related Info

Other Identifiers

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M25-491

Identifier Type: -

Identifier Source: org_study_id

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