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Completed

NCT Number: NCT06402513

A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

The objective of this study is to assess the pharmacokinetics, immunogenicity, safety, and tolerability, of subcutaneous formulation of ravagalimab in a pre-filled syringe 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# 265325

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 Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m^2 after rounding to the tenth decimal at screening.
  • 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.

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.
  • Participant using any over the counter and/or prescription medication, vitamins and/or herbal supplements, with the exception contraceptives or hormonal replacement therapies for females, on a regular basis.
  • History of any clinically significant sensitivity or allergy to any medication or food.
  • No prior exposure to ravagalimab
  • 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.

Treatment and study plan

Ravagalimab

Drug

Subcutaneous Injection

Other names: ABBV-323

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Approximately up to 71 days

    Maximum Observed Plasma Concentration (Cmax)

  2. Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: Approximately up to 71 days

    Time to Maximum Observed Plasma Concentration (Tmax)

  3. Apparent Terminal Phase Elimination Rate Constant (β)

    Time frame: Approximately up to 71 days

    Apparent Terminal Phase Elimination Rate Constant (β)

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

    Time frame: Approximately up to 71 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 71 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 71 days

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

  7. Number of Anti-drug antibody (ADA) Titers

    Time frame: Approximately up to 71 days

    Incidence of anti-drug antibodies

  8. Number of Participants with Adverse Events

    Time frame: Approximately up to 85 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 Adult Subjects to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 7, 2024
Registry last updated
Oct 21, 2024

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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