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

NCT06268860 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: 20220015
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Serum Concentration (Cmax) of Rocatinlimab

  Up to Day 112

• Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab

  Up to Day 112

• AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab

  Up to Day 112

Secondary Outcomes (3)

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)

  Up to approximately 20 weeks

• Number of Participants Experiencing Serious Adverse Events (SAE)

  Up to approximately 20 weeks

• Number of Participants Positive to Anti-rocatinlimab Antibody

  Up to Day 112

Study Arms (2)

Rocatinlimab Vial

EXPERIMENTAL

Participants will receive rocatinlimab vial solution SC

Drug: Rocatinlimab vial injection

Rocatinlimab Prefilled Syringe

EXPERIMENTAL

Participants will receive rocatinlimab prefilled syringe solution SC

Combination Product: Rocatinlimab prefilled syringe

Interventions

Rocatinlimab vial injection DRUG

Vial solution for SC injection administered on Day 1

Also known as: AMG 451

Rocatinlimab Vial

Rocatinlimab prefilled syringe COMBINATION_PRODUCT

Prefilled syringe solution for SC injection administered on Day 1

Also known as: AMG 451

Rocatinlimab Prefilled Syringe

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided informed consent before initiation of any study-specific activities/procedures.
• Healthy male or female participants, between 18 and 65 years of age (inclusive)
• Body mass index between 18 and 32 kg/m\^2 (inclusive)

You may not qualify if:

• 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.
• History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the electrocardiogram (ECG) taken at Check-in.
• 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.
• Systolic blood pressure \> 140 mmHg or \< 90 mmHg, or diastolic blood pressure \> 90 mmHg, or pulse rate \> 100 bpm
• 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.
• Estimated glomerular filtration rate less than 70 mL/min/1.73 m\^2
• Alanine aminotransferase or aspartate aminotransferase \> 1.5 times the upper limit of normal at Screening or Check-in.
• 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.
• 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.
• 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.
• 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:
• Acetaminophen (paracetamol) (up to 2 g per day) for analgesia will be allowed.
• Hormonal contraception listed in Appendix 3 will be allowed.
• Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed.

Sponsors & Collaborators

• Amgen: lead

Study Sites (4)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

Location

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, 75247-4903, United States

Location

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

Location

Fortrea Clinical Research Unit Limited - Leeds

Leeds, LDS, LS2 9LH, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: February 15, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 8, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (3); GB (1)