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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: ABBV-701; Drug: ABBV-701

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • CenExel ACT- Anaheim Clinical Trials /ID# 278431
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 273354

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Group 1 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose A or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 1: Group 2 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose B or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 1: Group 3 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose C or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 1: Group 4 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose D or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 1: Group 5 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose E or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 2: Group 6 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose E or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 2: Group 7 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose E or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 3: Group 8 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose C or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 3: Group 9 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose E or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 3: Group 10 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose F or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 4: Group 11 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose F or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion
Experimental: Part 4: Group 12 ABBV-701 or Placebo; Participants will receive a single dose of either ABBV-701 Dose F or placebo.	Drug: Placebo; IV infusion; Drug: Placebo; Subcutaneous; Drug: ABBV-701; Subcutaneous; Drug: ABBV-701; IV Infusion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; ABBV-701
• Other Study ID Numbers: M25-491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No