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NCT06148181 | COMPLETED | Healthy Volunteers

A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants
Sponsor:

AbbVie

Brief Summary:

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.

Condition or disease

Healthy Volunteers

Intervention/treatment

ABBV-141

Placebo for ABBV-141

ABBV-141

Placebo for ABBV-141

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 41 participants
Masking : DOUBLE
Primary Purpose : BASIC_SCIENCE
Official Title : A Randomized, Double-blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses of ABBV-141 in Healthy Adult Western and Asian Subjects
Actual Study Start Date : 2024-01-29
Estimated Primary Completion Date : 2024-12-30
Estimated Study Completion Date : 2024-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
  • * Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal.
  • For Part 2 only
    • -Han Chinese ethnicity or Japanese ethnicity based on the following criteria
      • * Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.
      • * Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.
      Exclusion Criteria
      • * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
      • * History of any clinically significant sensitivity or allergy to any medication, topical creams, or food.
      • Additionally for Part 1, only
        • * Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.
        • * History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
        • * History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.
        • * Evidence of hypertrophic scarring.
A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants

Location Details

NCT06148181

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Illinois

Question /Eid# 261162

Grayslake, Illinois, United States, 60030