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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06895343

Enrollment

100

Registered

2025-03-26

Start date

2025-04-03

Completion date

2026-11-01

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer, ABBV-701

Brief 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.

Interventions

DRUGABBV-701

Subcutaneous

DRUGPlacebo

Subcutaneous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Experiencing Adverse Events	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.
Maximum Plasma Concentration (Cmax) of ABBV-701	Up to approximately 47 weeks	Cmax of ABBV-701
Time to Cmax (Tmax) of ABBV-701	Up to approximately 47 weeks	Tmax of ABBV-701
Apparent terminal phase elimination rate constant (β) of ABBV-701	Up to approximately 47 weeks	(β) of ABBV-701
Terminal Phase Elimination Half-Life (t1/2) of ABBV-701	Up to approximately 47 weeks	(t1/2) of ABBV-701
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-701	Up to approximately 47 weeks	AUCt of ABBV-701
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701	Up to approximately 47 weeks	AUCinf of ABBV-701

Countries

United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026