Clinical trial NCT06214481: A Study to Evaluate Rocatinlimab (AMG 451) in Healthy Chinese Participants
Official title: A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rocatinlimab (AMG 451) Administered Subcutaneously in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Eczema
AMG 451
KHK4083
Rocatinlimab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the pharmacokinetics of rocatinlimab after single subcutaneous (SC) administration in healthy Chinese participants.


Eligibility criteria: Inclusion Criteria:

* Participants must be a resident in mainland China, and of Chinese ancestry (participants whose parents within 3 generations are of Chinese ancestry).
* Healthy male or female participants, between 18 and 65 years of age (inclusive) at the time of screening.
* Body mass index between 18 and 30 kg/m\^2 (inclusive) at the time of screening and check-in.
* Provide signed informed consent.

Exclusion Criteria:

* 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.
* Evidence of any active bacterial, viral, or fungal infection at screening including but not limited to upper or lower respiratory tract infection, conjunctivitis, acute otitis media, gastritis, enteritis, skin infections, infections requiring treatment with systemic therapy (antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals) for which therapy has not been completed within 4 weeks before enrollment.
* Immunocompromised participants at risk for viral reactivation including participants with history of solid organ transplantation, hematopoietic stem cell transplantation, or cellular therapy.
* Participants with disrupted skin integrity (apparent burn or dermatitis).
* Prior history of autoimmune disease including but not limited to inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), lupus, rheumatoid arthritis, psoriasis/psoriatic arthritis, multiple sclerosis.
* Positive hepatitis B surface antigen (HBsAg)/hepatitis B core antibody (HBcAb) or hepatitis C virus antibody and/or positive human immunodeficiency virus test, at screening. Participants whose hepatitis B and C results are compatible with prior immunity (resulting from inoculation) may be included.
* Positive T-spot test at screening.
* Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines within 120 days after administration of an investigational product.
* Participants who have received coronavirus disease 2019 vaccine within 30 days prior to check-in, or plan to receive a coronavirus disease 2019 vaccine within 120 days post-dose.
* Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.

  1. Acetaminophen (paracetamol; up to 2 g/day) for analgesia will be allowed.
  2. Hormone replacement therapy (e.g., estrogen) and hormonal contraceptives will be allowed.
* 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.
* Have previously completed or withdrawn from this study or any other study investigating rocatinlimab or have previously received the investigational product.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Rocatinlimab
timeFrame: Up to day 126
measure: Area Under the Serum Concentration Time Curve (AUC) from Time Zero to the Time of the Last Measurable Concentration (AUClast) of Rocatinlimab
timeFrame: Up to day 126
measure: AUC from Time Zero to Infinity (AUCinf) of Rocatinlimab
timeFrame: Up to day 126
Secondary outcomes:
measure: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Up to day 126
measure: Number of Participants Experiencing Serious Adverse Events
timeFrame: Up to day 126
measure: Number of Participants who Develop Anti-rocatinlimab Antibodies
timeFrame: Up to day 126
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University?
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: