A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Participants

Healthy Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002025
• Other study ID #: CR108267
• Secondary ID: 64304500CRD1001
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2016
• Last updated: September 27, 2017
• Start date: January 10, 2017
• Est. completion date: September 9, 2017

Study information

• Verified date: September 2017
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 9, 2017
• Est. primary completion date: September 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of the study including the procedures required and are willing to participate in the study

• Participant must be willing and able to adhere to the study visit schedule, prohibitions and restrictions specified in the protocol, and other protocol requirements

• Participant must have a body weight in the range of 60 to 90 kilogram (kg), inclusive, and a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^2)

• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator

• Participant must be a non-smoker for at least 3 months prior to study enrollment

Exclusion Criteria:

• Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, 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 results

• Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection

• Participant 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 2 months prior to screening

• Participant has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, and aspergillosis) prior to screening

• Participant has a history of active granulomatous infection, including histoplasmosis or coccidioidomycosis prior to screening

• If participant has had a chest radiograph within 3 months before study drug administration radiograph that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-64304500
Participants will receive JNJ-64304500 as SC injection.
• Placebo
Participants will receive matching placebo to JNJ-64304500 as SC injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability		Up to End of Study (Day 112)
Secondary	Maximum Observed Serum Concentration (Cmax)	The Cmax is the maximum observed serum analyte concentration.	Up to End of Study (Day 112)
Secondary	Time to Reach Maximum Observed Serum Concentration (Tmax)	The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.	Up to End of Study (Day 112)
Secondary	Elimination Half-Life (t1/2)	Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).	Up to End of Study (Day 112)
Secondary	Apparent Volume of Distribution (Vd/F)	The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].	Up to End of Study (Day 112)
Secondary	Apparent Total Clearance (CL/F)	The CL/F is defined as Dose/AUC (0-infinity).	Up to End of Study (Day 112)
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])	The AUC (0-last) is the area under the serum concentration-time curve from time zero to last quantifiable time.	Up to End of Study (Day 112)
Secondary	Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])	The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.	Up to End of Study (Day 112)
Secondary	Antibodies to JNJ-64304500	Serum samples will be collected and screened for antibodies binding to JNJ-64304500 and the titer of confirmed positive samples will be reported.	Up to End of Study (Day 112)
Secondary	Percentage of Natural Killer Group 2 Member D Receptor Occupancy (NKG2D RO) by JNJ-64304500	Percentage of NKG2D receptors on natural killer (NK) cells and cluster of differentiation 8 (CD8)+ T cells that are occupied by JNJ-64304500 will be analyzed using a validated flow cytometry assay.	Up to End of Study (Day 112)