Atopic Dermatitis
Conditions
Keywords
Rocatinlimab, AMG 451, Dermatology, Pharmacokinetics, Safety
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.
Interventions
DRUGRocatinlimab
Vial supplied as a single-use preservative free solution for SC injection.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 60 years of age (inclusive) 3. Body mass index between 18 and 32 kg/m2 (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 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 ≤ 50 mmHg, or pulse rate ≥ 100 bpm or ≤ 40 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 m2 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Approximately 20 weeks | TEAEs are any adverse events (AEs) that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECG), and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs. A serious AE (SAE) is defined as any 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. |
| Number of Participants with Anti-rocatinlimab Antibodies | Up to approximately Day 112 | — |
Countries
United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed