HealthyPhase 1NCT03080987
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants
A Phase 1 study testing JNJ-64179375 0.3 mg/kg, JNJ-64179375 1.0 mg/kg and JNJ-64179375 2.5 mg/kg in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in 2 countries.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-64179375 0.3 mg/kg, JNJ-64179375 1.0 mg/kg and JNJ-64179375 2.5 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Jun 2017to 25 Jun 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents
- Body mass index (weight kg/m^2) between 18 and 27 kilogram per square meter (kg/m^2) (inclusive), and body weight greater than 50 kg but less than 100 kg
- Generally in good health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
- Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
- Clinically significant abnormal physical exam at Screening or Day -1
- Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
- Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Hammersmith Medicines Research Ltd
London, NW10 7EW
About this study
Official title: A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Subjects
The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.
- Conditions
- Healthy
- Being tested
- JNJ-64179375 0.3 mg/kg, JNJ-64179375 1.0 mg/kg, JNJ-64179375 2.5 mg/kg, Placebo, JNJ-64179375 (Dose to be Determined)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64179375 0.3 mg/kgDrug
JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.
JNJ-64179375 1.0 mg/kgDrug
JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 2.5 mg/kgDrug
JNJ-64179375 2.5 mg/kg IV infusion on Day 1.
PlaceboOther
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 (Dose to be Determined)Drug
JNJ-64179375 IV infusion (Dose to be determined).
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo) | Experimental | Participants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1. Receives: Drug: JNJ-64179375 0.3 mg/kg; Other: Placebo |
| Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo) | Experimental | Participants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1. Receives: Drug: JNJ-64179375 1.0 mg/kg; Other: Placebo |
| Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo) | Experimental | Participants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1. Receives: Drug: JNJ-64179375 2.5 mg/kg; Other: Placebo |
| Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo) | Experimental | Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1. Receives: Other: Placebo; Drug: JNJ-64179375 (Dose to be Determined) |
| Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo) | Experimental | Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1. Receives: Other: Placebo; Drug: JNJ-64179375 (Dose to be Determined) |
| Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo) | Experimental | Participants will receive a single subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching Placebo on Day 1. Receives: Drug: JNJ-64179375 1.0 mg/kg; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to Day 113
Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to Day 113
Secondary outcomes (19)
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375
Cmax is the maximum observed plasma concentration.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1: Total Systemic Clearance (CL) of JNJ-64179375
CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375
Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375
Half-life is the time measured for the plasma concentration of drug to decrease by one half.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose
CL/F is defined as total systemic clearance over bioavailability after SC administration.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375
(Vz/F) is defined as Apparent Volume of distribution at terminal phase over bioavailability after SC administration of JNJ-64179375.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375
F is defined as absolute bioavailability after SC administration of JNJ-64179375.
Measured: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Immunogenicity of JNJ-64179375
Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.
Measured: Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in thrombin time (TT).
Measured: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in prothrombin time (PT).
Measured: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in activated partial thromboplastin time (aPTT).
Measured: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in Ecarin Clotting time (ECT).
Measured: Predose, Day 1, 2, 4, and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function
Platelet function will be assessed by measuring platelet activation and aggregation in response to thrombin and other agonists and with the platelet function analyzer (PFA)100.
Measured: Predose, Days 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)
The TGA is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual.
Measured: Predose, Day 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer
The D-dimer assay is an enzyme immunoassay procedure for the quantitative determination of D-dimer.
Measured: Predose, Day 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in international normalized ratio (INR).
Measured: Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Measured: Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start27 Jun 2017
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080987
- Sponsor's protocol ID
- CR108306
- Other IDs
- 2016-004785-25, 64179375EDI1002, 2016
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2017
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03080987
- Acronym / sponsor ID
- CR108306
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 15 Mar 2017 (actual)
- 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.
The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo) | Experimental | Drug: JNJ-64179375 0.3 mg/kg, Other: PlaceboParticipants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1. |
| Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo) | Experimental | Drug: JNJ-64179375 1.0 mg/kg, Other: PlaceboParticipants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1. |
| Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo) | Experimental | Drug: JNJ-64179375 2.5 mg/kg, Other: PlaceboParticipants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1. |
| Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo) | Experimental | Other: Placebo, Drug: JNJ-64179375 (Dose to be Determined)Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1. |
| Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo) | Experimental | Other: Placebo, Drug: JNJ-64179375 (Dose to be Determined)Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1. |
| Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo) | Experimental | Drug: JNJ-64179375 1.0 mg/kg, Other: PlaceboParticipants will receive a single subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching Placebo on Day 1. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents
- Body mass index (weight kg/m^2) between 18 and 27 kilogram per square meter (kg/m^2) (inclusive), and body weight greater than 50 kg but less than 100 kg
- Generally in good health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
- Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
- Clinically significant abnormal physical exam at Screening or Day -1
- Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
- Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
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-64179375 0.3 mg/kgJNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1. | Drug | Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo) |
| JNJ-64179375 1.0 mg/kgJNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2). | Drug | Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo), Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo) |
| JNJ-64179375 2.5 mg/kgJNJ-64179375 2.5 mg/kg IV infusion on Day 1. | Drug | Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo) |
| PlaceboMatching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2). | Other | Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo), Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo), Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo), Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo), Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo), Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo) |
| JNJ-64179375 (Dose to be Determined)JNJ-64179375 IV infusion (Dose to be determined). | Drug | Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo), Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo) |
Primary outcome
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Day 113
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Day 113
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
19 secondary outcomes
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1: Total Systemic Clearance (CL) of JNJ-64179375
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375
Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Immunogenicity of JNJ-64179375
Time frame: Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)
Time frame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)
Time frame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)
Time frame: Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)
Time frame: Predose, Day 1, 2, 4, and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function
Time frame: Predose, Days 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)
Time frame: Predose, Day 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer
Time frame: Predose, Day 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)
Time frame: Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375
Time frame: Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
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 3 Feb 2025.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-64179375 0.3 mg/kg, JNJ-64179375 1.0 mg/kg and JNJ-64179375 2.5 mg/kg in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in 2 countries.
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 4 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 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, United Kingdom. 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?
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: Up to Day 113). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.