A Study of JNJ-77474462 in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Anakinra; Drug: JNJ-77474462

Study type: Interventional

Funder types: Industry

Identifiers

NCT04544813

CR108771

77474462ADM1001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.

Enrollment: 78 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. 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
• Otherwise healthy on the basis of clinical laboratory tests performed at screening and Day 1. If the results of the serum chemistry panel, 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
• A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta hCG) at screening and a negative urine pregnancy test on Day -1
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days post study intervention administration
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention

Exclusion criteria

• 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 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 of recurrence
• Has or has had a serious infection (example: sepsis, pneumonia, or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 4 months prior to the screening visit
• 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)
• Has received prescription medications within 2 weeks prior to first study intervention administration

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 10 patient groups

Cohort A: JNJ-77474462 SC (Wave 1)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 subcutaneously (SC).

Treatment:

Drug: JNJ-77474462

Cohort B: JNJ-77474462 SC (Wave 1)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 SC.

Treatment:

Drug: JNJ-77474462

Cohort C: JNJ-77474462 SC (Wave 1)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 SC.

Treatment:

Drug: JNJ-77474462

Cohort D: JNJ-77474462 SC (Wave 1)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 SC.

Treatment:

Drug: JNJ-77474462

Cohort E: JNJ-77474462 IV (Wave 1)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 intravenously (IV).

Treatment:

Drug: JNJ-77474462

Cohort F: JNJ-77474462 SC (Wave 2)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 SC.

Treatment:

Drug: JNJ-77474462

Cohort G: JNJ-77474462 SC (Wave 2)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 SC.

Treatment:

Drug: JNJ-77474462

Cohort H: JNJ-77474462 IV (Wave 2)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 IV.

Treatment:

Drug: JNJ-77474462

Cohort I: JNJ-77474462 IV (Wave 2)

Experimental group

Description:

Participants will receive single dose of JNJ-77474462 IV.

Treatment:

Drug: JNJ-77474462

Cohort J: Anakinra SC

Active Comparator group

Description:

Participants will receive a SC injection of anakinra once daily for 3 days.

Treatment:

Drug: Anakinra