A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-64232025 in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-64232025 SC; Drug: JNJ-64232025 IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03550950

64232025ARA1001 (Other Identifier)

2017-003986-82 (EudraCT Number)

CR108448

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of JNJ-64232025 following single ascending intravenous (IV) study intervention administrations and a single subcutaneous (SC) intervention administration in healthy participants.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female of non-childbearing potential (postmenopausal or permanently sterile)
• Have a body mass index (BMI) between 19 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2), and a body weight of 50 to 100 kilogram (kg), inclusive
• Healthy on the basis of medical history, a physical examination, vital signs, and 12 lead electrocardiogram (ECG) performed at screening
• Healthy on the basis of clinical laboratory tests performed at screening and Day -1
• A woman must have a negative highly sensitive serum pregnancy test at screening and a negative urine pregnancy test on Day -1

Exclusion criteria

• Has 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, neoplastic disease, renal or urinary tract diseases, or dermatological disease
• Has a disease or disease treatment associated with immune suppression or lymphopenia, these include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenism, and chronic granulomatous disease
• Has a personal history of or conditions associated with thromboembolic events or bleeding disorders, including (but not limited to) myocardial infarction (MI), cerebral vascular accident (CVA)/stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), hemophilia, or menometrorrhagia
• Has history of allergy or adverse reactions to shellfish, aluminum, aluminum hydroxide keyhole limpet hemocyanin (KLH), tetanus or tetanus toxoid or its excipients
• Has a known or suspected intolerance or hypersensitivity to 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-64232025 and its excipients used in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

48 participants in 2 patient groups

Single Ascending Dose (SAD) IV Cohort

Experimental group

Description:

Participants will receive single intravenous (IV) dose of JNJ-64232025 or placebo in Cohorts 1 to 6 on Day 1.

Treatment:

Drug: JNJ-64232025 IV

Drug: Placebo

Subcutaneous (SC) Cohort

Experimental group

Description:

Participants will receive single dose of JNJ-64232025 or placebo as SC injection.

Treatment:

Drug: JNJ-64232025 SC

Drug: Placebo