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

Atopic Dermatitis Clinical Trial

Official title:

A Phase 1 Open-label, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06268860
• Other study ID #: 20220015
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 15, 2024
• Est. completion date: August 29, 2024

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: August 29, 2024
• Est. primary completion date: August 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis

Intervention

Drug:
• Rocatinlimab vial injection
Vial solution for SC injection administered on Day 1

Combination Product:
• Rocatinlimab prefilled syringe
Prefilled syringe solution for SC injection administered on Day 1

Locations

Country	Name	City	State
United Kingdom	Fortrea Clinical Research Unit Limited - Leeds	Leeds	LDS
United States	Fortrea Clinical Research Unit - Dallas	Dallas	Texas
United States	Fortrea Clinical Research Unit - Daytona Beach	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax) of Rocatinlimab		Up to Day 112
Primary	Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab		Up to Day 112
Primary	AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab		Up to Day 112
Secondary	Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE)	TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.	Up to approximately 20 weeks
Secondary	Number of Participants Experiencing Serious Adverse Events (SAE)	A SAE is defined as any adverse event (AE) that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to approximately 20 weeks
Secondary	Number of Participants Positive to Anti-rocatinlimab Antibody		Up to Day 112

External Links

•   AmgenTrials clinical trials website