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Completed

NCT Number: NCT06148181

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 261162

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-141

Drug

Infusion; intravenous (IV)

Placebo for ABBV-141

Drug

Infusion; IV

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of ABBV-141

    Time frame: Up to Day 85

    Cmax of ABBV-141 will be assessed.

  2. Time to Cmax (Tmax) of ABBV-141

    Time frame: Up to Day 85

    Tmax of ABBV-141 will be assessed.

  3. Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)

    Time frame: Up to Day 85

    AUCt of ABBV-141 will be determined.

  4. AUC of ABBV-141 from Time 0 to Infinity (AUCinf)

    Time frame: Up to Day 85

    AUCinf of ABBV-141 will be assessed.

  5. Terminal Phase Elimination Rate Constant (β) of ABBV-141

    Time frame: Up to Day 85

    Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.

  6. Terminal Phase Elimination Half-life (t1/2) of ABBV-141

    Time frame: Up to Day 85

    Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.

  7. Dose Normalized Cmax of ABBV-141

    Time frame: Up to Day 85

    Dose normalized Cmax of ABBV-141 will be assessed.

  8. Dose Normalized AUC of ABBV-141

    Time frame: Up to Day 85

    Dose normalized AUC of ABBV-141 will be assessed.

  9. Number of Adverse Events (AEs)

    Time frame: Baseline to Day 85

    An adverse event (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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2023
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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