Clinical trial NCT06438263: A Study to Evaluate Bioavailability of Rocatinlimab Autoinjector and Vial in Healthy Participants
Official title: An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess the Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Rocatinlimab
AMG 451
Dermatology
Pharmacokinetics
Safety
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-05-31
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Rocatinlimab
timeFrame: Up to approximately 112 days
measure: Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab
timeFrame: Up to approximately 112 days
measure: AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab
timeFrame: Up to approximately 112 days
Secondary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Approximately 20 weeks
measure: Number of Participants with Anti-rocatinlimab Antibodies
timeFrame: Up to approximately Day 112
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit - Daytona Beach
state: Florida
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit - Dallas
state: Texas
city: Madison
country: United States
facility: Fortrea Clinical Research Unit Inc. - Madison
state: Wisconsin
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: