A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants

NCT06438263 | Completed Phase 1 FDA Drug

• 1 other identifier: 20220014
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Rocatinlimab; AMG 451; Dermatology; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of Rocatinlimab

  Up to approximately 112 days

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

  Up to approximately 112 days

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

  Up to approximately 112 days

Secondary Outcomes (2)

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

  Approximately 20 weeks

• Number of Participants with Anti-rocatinlimab Antibodies

  Up to approximately Day 112

Study Arms (2)

Treatment A

EXPERIMENTAL

Participants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection.

Drug: Rocatinlimab

Treatment B

EXPERIMENTAL

Participants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection.

Drug: Rocatinlimab

Interventions

Rocatinlimab DRUG

Vial supplied as a single-use preservative free solution for SC injection.

Also known as: AMG 451

Treatment A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 60 years of age (inclusive)
• Body mass index between 18 and 32 kg/m2 (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 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 ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 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 m2
• 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 (3)

Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, 32117-5116, United States

Location

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, 75247-4968, United States

Location

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

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: May 27, 2024
• First Posted: May 31, 2024
• Study Start: August 6, 2024
• Primary Completion: May 3, 2025
• Study Completion: July 2, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.

Locations

US (3)