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Active, not recruitingNCT06895343Updated Mar 2, 2026

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 interventional study of ABBV-701 and Placebo in Healthy Volunteer, sponsored by AbbVie. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by AbbVie · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Healthy Volunteer
  • ABBV-701
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Part 1: Group 1 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 1: Group 2 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 1: Group 3 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 1: Group 4 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 1: Group 5 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 2: Group 6 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 2: Group 7 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 3: Group 8 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 3: Group 9 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 3: Group 10 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 4: Group 11 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

  • Experimental
    Part 4: Group 12 ABBV-701 or Placebo

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

    Drug: ABBV-701 · Drug: Placebo

Interventions

  • DrugABBV-701

    Subcutaneous

  • DrugPlacebo

    Subcutaneous

  • DrugABBV-701

    IV Infusion

  • DrugPlacebo

    IV infusion

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 47 weeks

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

    Cmax of ABBV-701

    Time frame: Up to approximately 47 weeks

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

    Tmax of ABBV-701

    Time frame: Up to approximately 47 weeks

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

    (β) of ABBV-701

    Time frame: Up to approximately 47 weeks

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

    (t1/2) of ABBV-701

    Time frame: Up to approximately 47 weeks

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

    AUCt of ABBV-701

    Time frame: Up to approximately 47 weeks

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

    AUCinf of ABBV-701

    Time frame: Up to approximately 47 weeks

07

Study locations

2 sites
  • CenExel ACT- Anaheim Clinical Trials /ID# 278431
    Anaheim, California 92801, United States
  • Acpru /Id# 273354
    Grayslake, Illinois 60030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06895343
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Mar 26, 2025
Start date
Apr 3, 2025
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Mar 2, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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