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Active, Not Recruiting

NCT Number: NCT06895343

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT- Anaheim Clinical Trials /ID# 278431, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-701

Drug

Subcutaneous

Placebo

Drug

Subcutaneous

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 47 weeks

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  2. Maximum Plasma Concentration (Cmax) of ABBV-701

    Time frame: Up to approximately 47 weeks

    Cmax of ABBV-701

  3. Time to Cmax (Tmax) of ABBV-701

    Time frame: Up to approximately 47 weeks

    Tmax of ABBV-701

  4. Apparent terminal phase elimination rate constant (β) of ABBV-701

    Time frame: Up to approximately 47 weeks

    (β) of ABBV-701

  5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-701

    Time frame: Up to approximately 47 weeks

    (t1/2) of ABBV-701

  6. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-701

    Time frame: Up to approximately 47 weeks

    AUCt of ABBV-701

  7. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701

    Time frame: Up to approximately 47 weeks

    AUCinf of ABBV-701

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-701 in Healthy Adult Western and Asian Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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