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OpenTrials
Completed

NCT Number: NCT05556226

Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants

This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.

ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.

All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.

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Key information

Conditions

ABBV-154

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 250429, Grayslake, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.

Exclusion criteria

  • Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
  • Prior exposure to similar biologic therapies.

Treatment and study plan

ABBV-154 Dose Formulation A

Drug

Subcutaneous Injection

ABBV-154 Dose Formulation B

Drug

Subcutaneous Injection

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Approximately up to 58 days

    Maximum Observed Plasma Concentration (Cmax)

  2. Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: Approximately up to 58 days

    Time to Maximum Observed Plasma Concentration (Tmax)

  3. Apparent Terminal Phase Elimination Rate Constant (β)

    Time frame: Approximately up to 58 days

    Apparent Terminal Phase Elimination Rate Constant (β)

  4. The Terminal Phase Elimination Half-Life (t1/2)

    Time frame: Approximately up to 58 days

    The Terminal Phase Elimination Half-Life (t1/2)

  5. The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)

    Time frame: Approximately up to 58 days

    The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)

  6. The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)

    Time frame: Approximately up to 58 days

    The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)

  7. Number of Participants with Adverse Events

    Time frame: Approximately up to 72 days

    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. The investigator assesses the relationship of each event to the use of study.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2022
Registry last updated
Mar 13, 2023

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.