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HealthyPhase 1NCT03618160

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

A Phase 1 study testing JNJ-64565111 in people with Healthy, run by Janssen Pharmaceutical K.K. at 2 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-64565111
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
2 sitesJapan
Study dates
6 Aug 2018to 21 Jun 2019
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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Japan2 sites

  • Souseikai Hakata Clinic

    Fukuoka, 812-0025

  • Sumida Hospital

    Tokyo, 130-0004

Other trials in Japan

About this study

Official title: A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Japanese Subjects and An Open-label, Single Dose Study to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Subjects

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.

Conditions
Healthy
Being tested
JNJ-64565111, Placebo

What participants receive

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

  • JNJ-64565111Drug

    Participants in Cohorts 1 to 3 will receive a single SC low, medium, and high dose of JNJ-64565111 respectively on Day 1, participants in Cohorts 4 to 6 will receive weekly multiple SC low, high and medium dose of JNJ-64565111 respectively on Days 1, 8, 15, and 22, under fasted conditions. Participants in Cohort 7 will receive a single SC medium dose of JNJ-64565111 on Day 1, under fasted conditions.

  • PlaceboDrug

    Participants will receive SC injection of matching placebo on Day 1 in all cohorts of Part 1 and on Days 1, 8, 15, and 22 in Part 2 under fasted conditions.

Study groups in NCT03618160
Study groupRoleWhat they receive
Part 1: SAD (Cohort 1 to 3)ExperimentalParticipants 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.
Receives: Drug: JNJ-64565111; Drug: Placebo
Part 2: MAD (Cohort 4 to 6)ExperimentalParticipants 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.
Receives: Drug: JNJ-64565111; Drug: Placebo
Part 3: Single Dose (Cohort 7)ExperimentalParticipants 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.
Receives: Drug: JNJ-64565111

What is being measured

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

  1. Part 1 and Part 3: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.

    Measured: Up to Day 35

  2. Part 1: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111

    Cmax is defined as the maximum observed serum concentration.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  3. Part 1: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111

    Tmax is defined as the actual sampling time to reach maximum observed serum concentration of JNJ-64565111.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  4. Part 1: Area Under Serum Concentration Curve From Time 0 to Time of the Last Measurable Concentration (AUC[0-Last]) of JNJ-64565111

    AUC(0-Last) is defined as the AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) serum concentration.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  5. Part 1: Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC[0-Infinity]) of JNJ-64565111

    AUC (0-infinity) is defined as the area under the serum concentration-time curve from time zero to infinite time calculated as the sum of AUC(0-last) and Clast/ lambda (z); wherein AUC(0-last) is area under the serum concentration time curve from time zero to last measurable serum concentration, Clast is the last observed measurable (non-BQL) serum concentration, and lambda (z) is the apparent terminal elimination rate constant.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  6. Part 1: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111

    t1/2 is defined as the apparent terminal elimination half life, and is calculated as 0.693/lambda (z).

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  7. Part 1: Apparent Volume of Distribution (V/F) of JNJ-64565111

    V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (V/F) is influenced by the fraction absorbed and calculated as dose/(lambda (z)*AUC[0-infinity]).

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  8. Part 1: Total Apparent Clearance (CL/F) of JNJ-64565111

    CL/F is defined as the total apparent clearance of drug after extravascular administration calculated as: dose divided by AUC[0-infinity].

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  9. Part 2: Number of Participants With AEs as a Measure of Safety and Tolerability

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.

    Measured: Up to Day 72

  10. Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111

    Cmax is defined as the maximum observed serum concentration.

    Measured: Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

  11. Part 2: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111

    Tmax is defined as the actual sampling time to reach maximum observed serum concentration of JNJ-64565111.

    Measured: Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

  12. Part 2: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111

    t1/2 is defined as the apparent terminal elimination half life, and is calculated as 0.693/lambda (z).

    Measured: Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

  13. Part 2: Apparent Volume of Distribution (V/F) of JNJ-64565111

    V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (V/F) is influenced by the fraction absorbed and calculated as dose/(lambda (z)*AUCtau).

    Measured: Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

  14. Part 2: Total Apparent Clearance (CL/F) of JNJ-64565111

    CL/F is the total apparent clearance of drug after extravascular administration calculated as: dose divided by AUCtau.

    Measured: Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

  15. Part 2: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-64565111

    AUCtau is defined as the measure of the serum drug concentration from time zero to end of dosing interval.

    Measured: Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: 72, 96, 144, 168 hours postdose

  16. Part 2: Observed Serum Concentration Just Prior to the Beginning or the End of a Dosing Interval (Ctrough) of JNJ-64565111

    Ctrough is defined as the observed serum concentration just prior to the beginning or the end of a dosing interval.

    Measured: Day 8: Predose ; Day 15: Predose; Day 22: Predose, 168 hours postdose

  17. Part 2: Average Concentration Over the Dosing Interval Tau (T) at Steady State (Caverage,ss) of JNJ-64565111

    Caverage,ss is defined as area under the serum concentration time curve observed during a dosing interval (tau) at steady state) will be calculated as AUCtau/Tau.

    Measured: Day 22: Predose, 72, 96, 144, 168 hours postdose

  18. Part 2: Observed Accumulation Index (AR-AUC) of JNJ-64565111

    AR-AUC is determined after multiple dose administration of JNJ-64565111 and calculated by using the equation: AUCtau, Day 22 divided by AUCtau, Day 1.

    Measured: Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

Secondary outcomes (26)

  1. Part 1 and 3: Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-64565111

    Number of participants with anti-drug antibodies (ADAs) to JNJ-64565111 will be reported.

    Measured: Predose, 144 and 816 hours postdose

  2. Part 1 and Part 3: Change From Baseline in Body Weight

    Change from baseline in body weight will be reported.

    Measured: Baseline to Day 35

  3. Part 1 and Part 3: Change from Baseline in Fasting Plasma Glucose (FPG) Levels

    Change from baseline in FPG levels will be reported.

    Measured: Baseline to Day 35

  4. Part 1 and Part 3: Change From Baseline in Total Cholesterol

    Change from baseline in total cholesterol will be reported.

    Measured: Baseline to Day 35

  5. Part 1 and Part 3: Change From Baseline in Low Density Lipoprotein- Cholesterol (LDL-C)

    Change from baseline in LDL-C will be reported.

    Measured: Baseline to Day 35

  6. Part 1 and Part 3: Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)

    Change from baseline in HDL-C will be reported.

    Measured: Baseline to Day 35

  7. Part 1 and Part 3: Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C)

    Change from baseline in VLDL-C will be reported.

    Measured: Baseline to Day 35

  8. Part 1 and Part 3: Change From Baseline in Triglycerides

    Change from baseline in Triglycerides will be reported.

    Measured: Baseline to Day 35

  9. Part 1 and Part 3: Change From Baseline in Free Fatty Acids

    Change from baseline in free fatty acids will be reported.

    Measured: Baseline to Day 35

  10. Part 2: Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-64565111

    Number of participants with ADAs to JNJ-64565111 will be reported.

    Measured: Predose on Day 1, 8, 15, 22 and then at 144, 480, 720, 1200 hours postdose

  11. Part 2: Change From Baseline in Body Weight

    Change from baseline in body weight will be reported.

    Measured: Baseline to Day 72

  12. Part 2: Change From Baseline in Fasting Plasma Glucose (FPG) Levels

    Change from baseline in FPG levels will be reported.

    Measured: Baseline to Day 72

  13. Part 2: Change From Baseline in Total Cholesterol

    Change from baseline in total cholesterol will be reported.

    Measured: Baseline to Day 72

  14. Part 2: Change From Baseline in Low Density Lipoprotein- Cholesterol (LDL-C)

    Change from baseline in LDL-C will be reported.

    Measured: Baseline to Day 72

  15. Part 2: Change From Baseline in High-Density Lipoprotein-Choelsterol (HDL-C)

    Change from baseline in HDL-C will be reported.

    Measured: Baseline to Day 72

  16. Part 2: Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C)

    Change from baseline in VLDL-C will be reported.

    Measured: Baseline to Day 72

  17. Part 2: Change From Baseline in Triglycerides

    Change from baseline in triglycerides will be reported.

    Measured: Baseline to Day 72

  18. Part 2: Change From Baseline in Free Fatty Acids

    Change from baseline in free fatty acids will be reported.

    Measured: Baseline to Day 72

  19. Part 3: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111

    Cmax is defined as the maximum observed serum concentration.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  20. Part 3: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111

    Tmax is defined as the actual sampling time to reach maximum observed serum concentration of JNJ-64565111.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  21. Part 3: Area Under Serum Concentration Curve From Time 0 to Time of the Last Measurable Concentration (AUC[0-Last]) of JNJ-64565111

    AUC(0-Last) is defined as the AUC from time 0 to the time of the last measurable non-below quantification limit serum concentration.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  22. Part 3: Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC[0-Infinity]) of JNJ-64565111

    AUC (0-infinity) is defined as the area under the serum concentration-time curve from time zero to infinite time calculated as the sum of AUC(0-last) and Clast/ lambda (z); wherein AUC(0-last) is area under the serum concentration time curve from time zero to last measurable serum concentration, Clast is the last observed measurable (non-BQL) serum concentration, and lambda (z) is the apparent terminal elimination rate constant.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  23. Part 3: Apparent Terminal Elimination Rate Constant (Lambda [z]) of JNJ-64565111

    Lambda (z) is the apparent terminal elimination rate-constant, estimated by linear regression using the terminal log linear phase of the log transformed concentration vs time curve.

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  24. Part 3:Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111

    t1/2 is defined the apparent terminal elimination half life, and is calculated as 0.693/lambda (z).

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  25. Part 3: Apparent Volume of Distribution (V/F) of JNJ-64565111

    V/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (V/F) is influenced by the fraction absorbed and calculated as dose/(lambda (z)*AUC[0-infinity]).

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

  26. Part 3: Total Apparent Clearance (CL/F) of JNJ-64565111

    CL/F is defined as the total apparent clearance of drug after extravascular administration calculated as: dose divided by AUC[0-infinity].

    Measured: Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

Timeline

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

  1. First posted7 Aug 2018
  2. Study start6 Aug 2018
  3. Primary completion21 Jun 2019
  4. Study completion21 Jun 2019

Why it stopped: The results of leading Phase 2 trials did not meet all desired endpoints

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03618160
Sponsor's protocol ID
CR108497
Other IDs
64565111NAS1001
Status last verified
Jan 2025
First submitted
2 Aug 2018
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-64565111 in people with Healthy, run by Janssen Pharmaceutical K.K. at 2 sites 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 5 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: stopped early, 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 2 sites 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 was stopped early (reason given: The results of leading Phase 2 trials did not meet all desired endpoints). Results are not available in the source record.

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?

Part 1 and Part 3: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Up to Day 35). The study lists 18 primary outcomes in all. 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 NCT03618160.

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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