A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants

Last updated: November 15, 2024
Sponsor: Amgen
Overall Status: Completed

Phase

1

Condition

Atopic Dermatitis

Hives (Urticaria)

Skin Infections/disorders

Treatment

Rocatinlimab prefilled syringe

Rocatinlimab vial injection

Clinical Study ID

NCT06268860
20220015
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Participant has provided informed consent before initiation of any study-specific activities/procedures.

  2. Healthy male or female participants, between 18 and 65 years of age (inclusive)

  3. Body mass index between 18 and 32 kg/m^2 (inclusive)

Exclusion Criteria

  1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

  2. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the electrocardiogram (ECG) taken at Check-in.

  3. A QT interval corrected for heart rate using Fridericia's method (QTcF) > 450 msec in male participants or > 470 msec in female participants or history/evidence of long QT syndrome at Screening or Check-in.

  4. Systolic blood pressure > 140 mmHg or < 90 mmHg, or diastolic blood pressure > 90 mmHg, or pulse rate > 100 bpm

  5. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Participants with seasonal allergies will be permitted.

  6. Estimated glomerular filtration rate less than 70 mL/min/1.73 m^2

  7. Alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper limit of normal at Screening or Check-in.

  8. Positive hepatitis B or hepatitis C panel (including positive hepatitis B surface antigen [HBsAg] and/or positive hepatitis C antibody) and/or positive human immunodeficiency virus test at Screening. Participants whose results are compatible with prior hepatitis B vaccination (positive hepatitis B surface antibody, negative hepatitis B core antibody, negative HBsAg) or prior infection (positive hepatitis B core antibody, positive hepatitis B surface antibody, negative HBsAg) may be included.

  9. Participants who have received live vaccines within 5 weeks prior to Screening, or plan to receive live vaccines within 90 days after administration of an investigational product.

Inactive vaccination (e.g., non-live or nonreplicating agent), including coronavirus-2019 (COVID-19) vaccination, is allowed.

  1. History of latent tuberculosis or active chronic, recurrent, or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before Screening.

  2. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before Check-in, excluding the following:

  3. Acetaminophen (paracetamol) (up to 2 g per day) for analgesia will be allowed.

  4. Hormonal contraception listed in Appendix 3 will be allowed.

  5. Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed.

  6. All herbal medicines (e.g., St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee) and in consultation with the Sponsor.

  7. Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives, whichever is longer, prior to Check-in.

  8. Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received rocatinlimab.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Rocatinlimab prefilled syringe
Phase: 1
Study Start date:
February 15, 2024
Estimated Completion Date:
August 30, 2024

Connect with a study center

  • Fortrea Clinical Research Unit Limited - Leeds

    Leeds, LDS LS2 9LH
    United Kingdom

    Site Not Available

  • Fortrea Leeds Clinical Research Unit

    Leeds, Yorkshire LS2 9LH
    United Kingdom

    Site Not Available

  • Fortrea Clinical Research Unit - Daytona Beach

    Daytona Beach, Florida 32117-5116
    United States

    Site Not Available

  • Fortrea Daytona Beach Clinical Research Unit

    Daytona Beach, Florida 32117
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit - Dallas

    Dallas, Texas 75247-4903
    United States

    Site Not Available

  • Fortrea Dallas Clinical Research Unit

    Dallas, Texas 75247
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit Inc. - Madison

    Madison, Wisconsin 53704-2526
    United States

    Site Not Available

  • Fortrea Madison Clinical Research Unit

    Madison, Wisconsin 53704
    United States

    Active - Recruiting

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