Clinical trial NCT04544826: A Study of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of the study is to assess the safety and tolerability of JNJ-77474462 following single subcutaneous (SC) administration to healthy participants of Japanese descent.


Eligibility criteria: Inclusion Criteria:

* Participant must be of first to third generation Japanese descent
* Participant must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-1. Any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Participant must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day-1. If the results of the serum chemistry panel including hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height\^2) and a body weight of between 50 to 90 kg inclusive
* A female participant must have a negative pregnancy test at screening and on Day -1

Exclusion Criteria:

* Coexisting Medical Conditions or Past Medical History: History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, endocrine, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* Coexisting Medical Conditions or Past Medical History: Has known allergies, hypersensitivity, or intolerance to JNJ-77474462 or its excipients, or any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-77474462 and its excipients used in this study
* Malignancy or Increased Potential for Malignancy: Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk and no evidence of recurrence within 5 years prior to screening
* Concomitant or Previous Medical Therapies Received: Participant is currently enrolled in an investigational study or has received an investigational intervention (including investigational vaccines or devices) 5 half-lives or 8 weeks prior to screening (whichever is longer)
* Concomitant or Previous Medical Therapies Received: Has received over the counter medications (including vitamins/multivitamins supplements, corticosteroids, acetaminophen/paracetamol, aspirin, decongestants, antihistamines and other non-steroidal anti-inflammatory drugs), and herbal medication (including, but not limited to, herbal tea, St. John's Wort, and cannabidol) within 2 weeks prior to first study intervention administration unless approved by the investigator and sponsor medical monitor
* Infections or Predisposition to Infections: has an active acute or clinically significant chronic infection

Primary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 16
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 16
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
timeFrame: Up to Week 16
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to Week 12
measure: Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
timeFrame: Up to Week 12
measure: Number of Participants with Clinically Significant Changes in Hematology
timeFrame: Up to Week 12
measure: Number of Participants with Clinically Significant Changes in Chemistry
timeFrame: Up to Week 12
measure: Number of Participants with Clinically Significant Changes in Urinalysis
timeFrame: Up to Week 12
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax)
timeFrame: Up to Week 12
measure: Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: Up to Week 12
measure: Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last])
timeFrame: Up to Week 12
measure: Time to Reach Maximum Observed Concentration (Tmax)
timeFrame: Up to Week 12
measure: Terminal Half-life (T1/2)
timeFrame: Up to Week 12
measure: Apparent Total Systemic Clearance (CL/F)
timeFrame: Up to Week 12
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Up to Week 12
measure: Number of Participants with Antibodies to JNJ-77474462
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Nucleus Network, Q-Pharm Pty Ltd
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: