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

NCT06895343 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-491
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-701

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (12)

Part 1: Group 1 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 1: Group 2 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 1: Group 3 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 1: Group 4 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 1: Group 5 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 2: Group 6 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 2: Group 7 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 3: Group 8 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 3: Group 9 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 3: Group 10 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 4: Group 11 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Part 4: Group 12 ABBV-701 or Placebo

EXPERIMENTAL

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

Drug: ABBV-701; Drug: Placebo

Interventions

ABBV-701 DRUG

Subcutaneous

Part 1: Group 1 ABBV-701 or Placebo; Part 1: Group 2 ABBV-701 or Placebo; Part 1: Group 3 ABBV-701 or Placebo; Part 1: Group 4 ABBV-701 or Placebo; Part 1: Group 5 ABBV-701 or Placebo; Part 2: Group 6 ABBV-701 or Placebo; Part 2: Group 7 ABBV-701 or Placebo

Placebo DRUG

Subcutaneous

Part 1: Group 1 ABBV-701 or Placebo; Part 1: Group 2 ABBV-701 or Placebo; Part 1: Group 3 ABBV-701 or Placebo; Part 1: Group 4 ABBV-701 or Placebo; Part 1: Group 5 ABBV-701 or Placebo; Part 2: Group 6 ABBV-701 or Placebo; Part 2: Group 7 ABBV-701 or Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

CenExel ACT- Anaheim Clinical Trials /ID# 278431

Anaheim, California, 92801, United States

Location

Acpru /Id# 273354

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: April 3, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)