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

NCT ID: NCT06268860

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-10-08

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Rocatinlimab; AMG 451; Dermatology; Pharmacokinetics; Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rocatinlimab Vial

Participants will receive rocatinlimab vial solution SC

Group Type: EXPERIMENTAL

Rocatinlimab vial injection

Intervention Type: DRUG

Vial solution for SC injection administered on Day 1

Rocatinlimab Prefilled Syringe

Participants will receive rocatinlimab prefilled syringe solution SC

Group Type: EXPERIMENTAL

Rocatinlimab prefilled syringe

Intervention Type: COMBINATION_PRODUCT

Prefilled syringe solution for SC injection administered on Day 1

Interventions

Rocatinlimab vial injection

Vial solution for SC injection administered on Day 1

Intervention Type: DRUG

Rocatinlimab prefilled syringe

Prefilled syringe solution for SC injection administered on Day 1

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

AMG 451; AMG 451

Eligibility Criteria

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.

10. 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.

11. 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:

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

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

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

12. 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.

13. 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.

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 Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received rocatinlimab.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, United States

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, United States

Fortrea Clinical Research Unit Limited - Leeds

Leeds, LDS, United Kingdom

Countries

United States; United Kingdom

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20220015

Identifier Type: -

Identifier Source: org_study_id