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

Last updated: November 24, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Placebo

ABBV-701

Clinical Study ID

NCT06895343
M25-491
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body weight is ≥ 35 kg and BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to thetenth'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

Exclusion Criteria:

  • History of any clinically significant cardiovascular, respiratory (except mildasthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic, orpsychiatric disease or disorder, or any uncontrolled medical illness.

  • History of any clinically significant sensitivity or allergy to any medication orfood.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
April 03, 2025
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • CenExel ACT- Anaheim Clinical Trials /ID# 278431

    Anaheim 5323810, California 5332921 92801
    United States

    Active - Recruiting

  • Acpru /Id# 273354

    Grayslake, Illinois 60030
    United States

    Site Not Available

  • Acpru /Id# 273354

    Grayslake 4894465, Illinois 4896861 60030
    United States

    Active - Recruiting

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