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HealthyPhase 1NCT03002025

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

A Phase 1 study testing JNJ-64304500 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-64304500
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteJapan
Study dates
10 Jan 2017to 9 Sep 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Tokyo

Other trials in Japan

About this study

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

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.

Conditions
Healthy
Being tested
JNJ-64304500, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64304500Drug

    Participants will receive JNJ-64304500 as SC injection.

  • PlaceboDrug

    Participants will receive matching placebo to JNJ-64304500 as SC injection.

Study groups in NCT03002025
Study groupRoleWhat they receive
Cohort 1: JNJ-64304500 50 milligram (mg) or placeboExperimentalParticipants (Japanese) will receive single subcutaneous (SC) dose of JNJ-64304500 50 mg or placebo on Day 1.
Receives: Drug: JNJ-64304500; Drug: Placebo
Cohort 2: JNJ-64304500 150 mg or placeboExperimentalParticipants (Japanese) will receive single SC dose of JNJ-64304500 150 mg or placebo on Day 1.
Receives: Drug: JNJ-64304500; Drug: Placebo
Cohort 3: JNJ-64304500 400 mg or placeboExperimentalParticipants (Japanese) will receive single SC dose of JNJ-64304500 400 mg or placebo on Day 1.
Receives: Drug: JNJ-64304500; Drug: Placebo
Cohort 4: JNJ-64304500 150 mg or placeboExperimentalParticipants (Caucasian) will receive single subcutaneous (SC) dose of JNJ-64304500 150 mg or placebo on Day 1.
Receives: Drug: JNJ-64304500; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

    Measured: Up to End of Study (Day 112)

Secondary outcomes (9)

  1. Maximum Observed Serum Concentration (Cmax)

    The Cmax is the maximum observed serum analyte concentration.

    Measured: Up to End of Study (Day 112)

  2. Time to Reach Maximum Observed Serum Concentration (Tmax)

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

    Measured: Up to End of Study (Day 112)

  3. 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).

    Measured: Up to End of Study (Day 112)

  4. Apparent Volume of Distribution (Vd/F)

    The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].

    Measured: Up to End of Study (Day 112)

  5. Apparent Total Clearance (CL/F)

    The CL/F is defined as Dose/AUC (0-infinity).

    Measured: Up to End of Study (Day 112)

  6. 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.

    Measured: Up to End of Study (Day 112)

  7. 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.

    Measured: Up to End of Study (Day 112)

  8. 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.

    Measured: Up to End of Study (Day 112)

  9. 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.

    Measured: Up to End of Study (Day 112)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2016 (estimated)
  2. Study start10 Jan 2017
  3. Primary completion9 Sep 2017
  4. Study completion9 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03002025
Sponsor's protocol ID
CR108267
Other IDs
64304500CRD1001
Status last verified
Jan 2025
First submitted
21 Dec 2016
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64304500 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Up to End of Study (Day 112)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03002025.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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