HealthyPhase 1NCT02758392

A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants

A Phase 1 study testing JNJ-61178104 Intravenous and JNJ-61178104 Subcutaneous in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

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 purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose administration and a single Subcutaneous (SC) dose administration in healthy participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-61178104 Intravenous and JNJ-61178104 Subcutaneous
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteBelgium
Study dates: Apr 2016to Jan 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 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Participant must have a body weight in the range of 50 Kilogram (kg) to 100 kg, inclusive, and have a body mass index of 19 Kilogram per meter square (kg/m^2) to 30 kg/m2, inclusive
Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day-1. If the results of the serum chemistry panel including liver enzymes, hematology panel, 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 medical record with documented review confirmation by the investigator
Before randomization, a woman must not be of childbearing potential: a) Postmenopausal {greater than (>) 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 International Units Per Litre (IU/L) at Screening}; or b) Permanently sterilized (example, bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, oophorectomy); or c) Otherwise be incapable of pregnancy
Be considered eligible according to the following tuberculosis (TB) Screening criteria: a) Have no history of latent or active TB prior to Screening; b) Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; c) Have had no recent close contact with a person with active TB; d) Have a negative T-Spot TB test result at Screening

Who cannot join

Participant currently has or has a 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, cardiac, vascular, metabolic, endocrine, rheumatologic, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
Participant has a QT corrected according to Fridericia's formula (QTcF) interval >450 msec, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (example, heart failure, hypokalemia, family history of Long QT Syndrome) at Screening and at Day -1
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 17 weeks after the last dose of study drug administration
Participant plans to undergo non-major elective surgery within 4 weeks prior to study drug administration through the end of the study
Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-61178104 and its excipients used in this study

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Merksem

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Interventional Study of JNJ-61178104 in Healthy Subjects

Read the detailed description

This is a randomized, double-blind, placebo-controlled, single ascending dose, single site, interventional study. There will be 5 single ascending dose (SAD) IV cohorts and 1 SC cohort. Nine participants will be enrolled into each of 5 IV cohorts and 1 SC cohort and participants will be randomized at a ratio of 2:1 to receive JNJ-61178104 or placebo. The total duration of participants participation will be approximately 21 weeks including a Screening Visit up to 4 weeks prior to study drug administration. Participants will have an inpatient period consisting of 6 days/5 nights and will return to the study-site at Weeks 2, 3, 4, 5, 7, 9, 13, and 17. Participants will be evaluated for safety throughout the study.

Conditions: Healthy
Being tested: JNJ-61178104 Intravenous, JNJ-61178104 Subcutaneous, Placebo
Keywords: Healthy, JNJ-61178104, Placebo, Safety

What participants receive

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

JNJ-61178104 IntravenousDrug
Participants will receive JNJ-61178104 Intravenously on Day 1.
JNJ-61178104 SubcutaneousDrug
Participants will receive JNJ-61178104 Subcutaneously on Day 1.
PlaceboDrug
Participants will receive placebo on Day 1.

Study groups in NCT02758392
Study group	Role	What they receive
Dose 1: JNJ-61178104 OR Placebo IV	Experimental	Participants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1. Receives: Drug: JNJ-61178104 Intravenous; Drug: Placebo
Dose 2: JNJ-61178104 OR Placebo IV	Experimental	Participants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1. Receives: Drug: JNJ-61178104 Intravenous; Drug: Placebo
Dose 3: JNJ-61178104 OR Placebo IV	Experimental	Participants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1. Receives: Drug: JNJ-61178104 Intravenous; Drug: Placebo
Dose 4: JNJ-61178104 OR Placebo IV	Experimental	Participants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1. Receives: Drug: JNJ-61178104 Intravenous; Drug: Placebo
Dose 5: JNJ-61178104 OR Placebo IV	Experimental	Participants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1. Receives: Drug: JNJ-61178104 Intravenous; Drug: Placebo
Dose 6: JNJ-61178104 OR Placebo SC	Experimental	Participants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1. Receives: Drug: JNJ-61178104 Subcutaneous; Drug: Placebo

What is being measured

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

Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability
Measured: Day 113

Secondary outcomes (13)

Serum Concentration of JNJ-61178104
Measured: Up to Day 113
JNJ-61178104 Antibodies Concentration
Measured: Up to Day 113
Cytokine Concentrations
Measured: Predose, Up to Day 113
Maximum Observed Serum Concentration (Cmax) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Measured: Up to Day 113
Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Measured: Up to Day 113
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Measured: Up to Day 113
Serum Half-Life (t1/2) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Measured: Up to Day 113
Time to Reach Maximum Observed Serum Concentration (Tmax) Following Subcutaneous (SC) JNJ-61178104 Administration
Measured: Up to Day 113
Systemic Clearance (CL) Following Intravenous (IV) JNJ-61178104 Administration
Measured: Up to Day 113
Apparent Clearance (CL/F) Following Subcutaneous (SC) JNJ-61178104 Administration
Measured: Up to Day 113
Volume of Distribution (Vz) Following Intravenous (IV) JNJ-61178104 Administration
Measured: Up to Day 113
Apparent Volume of Distribution (Vz/F) Following Subcutaneous (SC) JNJ-61178104 Administration
Measured: Up to Day 113
Absolute Bioavailability (F[abs]) Following Subcutaneous (SC) JNJ-61178104 Administration
The F is the percentage of the subcutaneously administered dose that is systemically available relative to an intravenous (IV) administration. It is calculated as (AUC [0-infinity] for 1 mg/kg SC JNJ-61178104)/(AUC [0-infinity] for 1 mg/kg IV JNJ-61178104 )*100, where the AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time.
Measured: Up to Day 113

Timeline

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

Apr 2016Jan 2017

First posted2 May 2016 (estimated)
Study startApr 2016
Primary completionJan 2017
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02758392
Sponsor's protocol ID: CR108162
Other IDs: 61178104NAP1001, 2015-004253-40, 2015
Status last verified: Jan 2017
First submitted: 14 Apr 2016
Last updated: 23 Jan 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Interventional Study of JNJ-61178104 in Healthy Subjects
ClinicalTrials.gov ID: NCT02758392
Acronym / sponsor ID: CR108162
Conditions: Healthy
Keywords: Healthy, JNJ-61178104, Placebo, Safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 2 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Dose 1: JNJ-61178104 OR Placebo IV	Experimental	Drug: JNJ-61178104 Intravenous, Drug: PlaceboParticipants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1.
Dose 2: JNJ-61178104 OR Placebo IV	Experimental	Drug: JNJ-61178104 Intravenous, Drug: PlaceboParticipants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1.
Dose 3: JNJ-61178104 OR Placebo IV	Experimental	Drug: JNJ-61178104 Intravenous, Drug: PlaceboParticipants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1.
Dose 4: JNJ-61178104 OR Placebo IV	Experimental	Drug: JNJ-61178104 Intravenous, Drug: PlaceboParticipants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1.
Dose 5: JNJ-61178104 OR Placebo IV	Experimental	Drug: JNJ-61178104 Intravenous, Drug: PlaceboParticipants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1.
Dose 6: JNJ-61178104 OR Placebo SC	Experimental	Drug: JNJ-61178104 Subcutaneous, Drug: PlaceboParticipants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Participant must have a body weight in the range of 50 Kilogram (kg) to 100 kg, inclusive, and have a body mass index of 19 Kilogram per meter square (kg/m^2) to 30 kg/m2, inclusive
Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day-1. If the results of the serum chemistry panel including liver enzymes, hematology panel, 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 medical record with documented review confirmation by the investigator
Before randomization, a woman must not be of childbearing potential: a) Postmenopausal {greater than (>) 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 International Units Per Litre (IU/L) at Screening}; or b) Permanently sterilized (example, bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, oophorectomy); or c) Otherwise be incapable of pregnancy
Be considered eligible according to the following tuberculosis (TB) Screening criteria: a) Have no history of latent or active TB prior to Screening; b) Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; c) Have had no recent close contact with a person with active TB; d) Have a negative T-Spot TB test result at Screening

Key exclusion criteria (5 listed)

Participant currently has or has a 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, cardiac, vascular, metabolic, endocrine, rheumatologic, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
Participant has a QT corrected according to Fridericia's formula (QTcF) interval >450 msec, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (example, heart failure, hypokalemia, family history of Long QT Syndrome) at Screening and at Day -1
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 17 weeks after the last dose of study drug administration
Participant plans to undergo non-major elective surgery within 4 weeks prior to study drug administration through the end of the study
Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-61178104 and its excipients used in this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JNJ-61178104 IntravenousParticipants will receive JNJ-61178104 Intravenously on Day 1.	Drug	Dose 1: JNJ-61178104 OR Placebo IV, Dose 2: JNJ-61178104 OR Placebo IV, Dose 3: JNJ-61178104 OR Placebo IV, Dose 4: JNJ-61178104 OR Placebo IV, Dose 5: JNJ-61178104 OR Placebo IV
JNJ-61178104 SubcutaneousParticipants will receive JNJ-61178104 Subcutaneously on Day 1.	Drug	Dose 6: JNJ-61178104 OR Placebo SC
PlaceboParticipants will receive placebo on Day 1.	Drug	Dose 1: JNJ-61178104 OR Placebo IV, Dose 2: JNJ-61178104 OR Placebo IV, Dose 3: JNJ-61178104 OR Placebo IV, Dose 4: JNJ-61178104 OR Placebo IV, Dose 5: JNJ-61178104 OR Placebo IV, Dose 6: JNJ-61178104 OR Placebo SC

Primary outcome

Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability
Time frame: Day 113

13 secondary outcomes

Serum Concentration of JNJ-61178104
Time frame: Up to Day 113
JNJ-61178104 Antibodies Concentration
Time frame: Up to Day 113
Cytokine Concentrations
Time frame: Predose, Up to Day 113
Maximum Observed Serum Concentration (Cmax) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Serum Half-Life (t1/2) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Time to Reach Maximum Observed Serum Concentration (Tmax) Following Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Systemic Clearance (CL) Following Intravenous (IV) JNJ-61178104 Administration
Time frame: Up to Day 113
Apparent Clearance (CL/F) Following Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Volume of Distribution (Vz) Following Intravenous (IV) JNJ-61178104 Administration
Time frame: Up to Day 113
Apparent Volume of Distribution (Vz/F) Following Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113
Absolute Bioavailability (F[abs]) Following Subcutaneous (SC) JNJ-61178104 Administration
Time frame: Up to Day 113

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-61178104 Intravenous and JNJ-61178104 Subcutaneous in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

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: finished, as of the sponsor's last update on 23 Jan 2017. 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 Belgium. 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 Following Study Drug Administration as a Measure of Safety and Tolerability (time frame: Day 113). 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 NCT02758392.

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 23 Jan 2017.