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

ABSTRACT

ConditionAtopic Dermatitis

InterventionDrug Rocatinlimab vial injection;Combination Product Rocatinlimab prefilled syringe

Primary outcome:Maximum Observed Serum Concentration (Cmax) of Rocatinlimab;Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab;AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab

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.