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Completed

NCT Number: NCT07136103

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants

The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in healthy adult participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 265681

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

  • Body weight ≥ 35 kg
  • Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile neurological examination, and a 12-lead ECG

Exclusion criteria

  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
  • Participant must meet pregnancy/conception/partner considerations criteria as detailed in the eligibility section.
  • Participants using any medications, vitamins and/or herbal supplements within the 14-day period prior to study drug administration or within 5 half-lives of the respective medication, whichever is longer.
  • History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
  • History of suicidal ideation currently or within one year prior to study drug administration as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C - SSRS completed at screening, or any history of suicide attempts within the last two years.

Treatment and study plan

ABBV-277

Drug
  • Intravenous (IV) infusion

Placebo

Drug
  • Intravenous (IV) infusion

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABBV-277

    Time frame: Up to approximately 9 days

    Cmax of ABBV-277

  2. Time to Cmax (Tmax) of ABBV-277

    Time frame: Up to approximately 9 days

    Tmax of ABBV-277

  3. Terminal Phase Elimination Rate Constant (Beta) of ABBV-277

    Time frame: Up to approximately 9 days

    Terminal phase elimination rate constant (beta) of ABBV-277

  4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-277

    Time frame: Up to approximately 9 days

    Terminal phase elimination half-life of ABBV-277

  5. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-277

    Time frame: Up to approximately 9 days

    AUCt of ABBV-277

  6. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-277

    Time frame: Up to approximately 9 days

    AUCinf of ABBV-277

  7. Number of Participants With Adverse Events (AEs)

    Time frame: Up to Day 196

    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 First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Jul 8, 2026

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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