A Study to Assess the Safety, Tolerability and Pharmacokinetics of Subcutaneous (SC) Injections of JNJ-64565111 in Healthy Male Japanese Participants and to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Participants

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-64565111

Study type: Interventional

Funder types: Industry

Identifiers

NCT03618160

64565111NAS1001 (Other Identifier)

CR108497

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-64565111 following single and multiple subcutaneous (SC) doses in healthy Japanese male participants.

Enrollment: 42 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• For Part 1 and Part 2, participant must be a Japanese male 20 to 65 years of age, inclusive, at the time of informed consent for screening. For Part 3, participant must be a Caucasian male (defined as white and all of his parents and grandparents are white as determined by participant's verbal report) 20 to 65 years of age, inclusive, at the time of informed consent for screening
• Participant must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during sexual intercourse (even in case of prior vasectomy), or to remain abstinent, and not to donate sperm during the study and for 90 days after study drug administration. Participants should encourage their female partner to use an effective method of contraception (example, prescription oral contraceptives, contraceptive injections, intrauterine device, or contraceptive patch) in addition to the condom used by the male study participant
• Participant must have a body mass index (BMI) ranging from 25 to 40 kilogram per meter square (kg/m^2), weighing 120 kilogram (kg) or less
• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening
• Participant must be a non smoker for at least 1 month prior to screening. A positive urine smoking test (cotinine) at screening and/or admission (Day 2) will lead to exclusion

Exclusion criteria

• Participant having a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiovascular disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), significant pulmonary disease, including bronchospastic respiratory disease, hepatic or renal insufficiency, type 1 diabetes mellitus, type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study result
• Participant has taken any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, from 14 days before the first dose of the study drug is scheduled until completion of the study
• Participant has received an experimental drug (including investigational vaccines) or used an experimental medical device within 3 months or within a period less than 5 times the drug's half life, whichever is longer, prior to screening
• Participant test positive for human immunodeficiency virus (HIV [positive serology for HIV antigen/antibody]), tests positive for hepatitis B virus surface antigen, or has antibodies to hepatitis C virus (HCV) at screening
• Participant has had major surgery (example, requiring general anesthesia) within 4 months before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after study drug administration

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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42 participants in 3 patient groups

Part 1: SAD (Cohort 1 to 3)

Experimental group

Description:

Participants in Cohorts 1 to 3 will receive a single Subcutaneous (SC) low, medium, and high dose of JNJ-64565111 or a JNJ-64565111 matched placebo respectively on Day 1, under fasted conditions in healthy Japanese male participants. Doses in subsequent cohorts will be escalated based on review of Principal Investigator and the Sponsor's decision after safety, tolerability review to determine safe and maximum well tolerated dose.

Treatment:

Drug: JNJ-64565111

Drug: Placebo

Part 2: MAD (Cohort 4 to 6)

Experimental group

Description:

Participants in Cohorts 4 to 5 will receive weekly multiple SC low and high dose of JNJ-64565111 or a JNJ-64565111 matched placebo respectively on Day 1, under fasted conditions in healthy Japanese male participants. If multiple high dose is judged as not tolerable, additional optional Cohort 6 will be added to Part 2 to investigate the safety, tolerability and PK after administration of multiple medium dose of JNJ-64565111 in healthy Japanese male participants. Doses in subsequent cohorts will be escalated based on review of Principal Investigator and the Sponsor's decision after safety and tolerability review to determine safe and maximum well tolerated dose.

Treatment:

Drug: JNJ-64565111

Drug: Placebo

Part 3: Single Dose (Cohort 7)

Experimental group

Description:

Participants in Cohort 7 will receive a single SC medium dose of JNJ-64565111 which may be started (as early as) in parallel with Cohort 3 in Part 1 on Day 1, under fasted conditions in healthy Caucasian male participants. Based on the results from Cohort 1 to 3 in Part 1, the dose of Cohort 7 may be reduced to low dose or increased to high dose.

Treatment:

Drug: JNJ-64565111