HealthyPhase 1NCT04223349
A Study of JNJ-70033093 (BMS-986177) in Healthy Adult Participants
A Phase 1 study testing JNJ-70033093 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to characterize the pharmacokinetic (PK) of multiple twice-daily doses of JNJ-70033093 in healthy participants and to assess the effects of dosing time and food on the PK of single-dose of JNJ-70033093 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-70033093
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 8 Apr 2020
- 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
- Healthy on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis performed at screening. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta-hCG]) at screening and urine (beta-hCG) pregnancy test on Day -1 of treatment period
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- Body mass index (BMI; weight kilogram per meter square [kg/m^2]) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kilogram (kg)
- After being supine for 10 minutes, systolic blood pressure between 90 and 140 millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood pressure
Who cannot join
- If a woman, pregnant, breast-feeding or planning to become pregnant during the study
- History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to any known bleeding or clotting disorder, a history of arterial or venous thrombosis, liver or renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic abnormalities, metabolic disturbances, or poor venous access
- Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection at study screening
- History of, or a reason to believe a participant has a history of, drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM V) criteria within the past 1 year, which in the investigator's opinion would compromise participant safety and/or compliance with the study procedures
- History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation. History of allergy to or unwillingness to consume any component of the high-fat breakfast menu to be provided in this study
- Clinically significant abnormal values for hematology, coagulation, clinical chemistry or urinalysis at Screening or on Day -1 prior to the first dosing as determined by the investigator or appropriate designee. Any of the following laboratory results outside of the ranges specified below at screening or Day -1 prior to first dosing, confirmed by repeat: Hemoglobin or hematocrit < lower limit of normal; Platelet count < lower limit of normal; activated partial thromboplastin time (aPTT), or prothrombin time (PT) greater than (>) 1.2 × upper limit of normal (ULN)
- Any of the following on 12-lead ECG and assessment of QT interval prior to study treatment administration, confirmed by repeat at screening and Day -1 of treatment period: Heart rate >100 beats per minute (bpm); PR >= 210 milli second (ms); QRS >=120 ms; QTcF >= 450 ms for male and >= 470 ms for female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Single-dose Crossover, and Double-blind Multiple-dose Parallel Group Study to Characterize the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of JNJ-70033093 in Healthy Adult Subjects
The purpose of this study is to characterize the pharmacokinetic (PK) of multiple twice-daily doses of JNJ-70033093 in healthy participants and to assess the effects of dosing time and food on the PK of single-dose of JNJ-70033093 in healthy participants.
- Conditions
- Healthy
- Being tested
- JNJ-70033093, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-70033093Drug
JNJ-70033093 capsules will be administered orally .
PlaceboDrug
Matching placebo in capsule will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Treatment A | Experimental | Participants will receive JNJ-70033093 dose twice daily (BID) for 8 days followed by a placebo dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. Receives: Drug: JNJ-70033093; Drug: Placebo |
| Part 1: Treatment B | Experimental | Participants will receive JNJ-70033093 dose BID for 8 days followed by a placebo dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. Receives: Drug: JNJ-70033093; Drug: Placebo |
| Part 1: Treatment C | Experimental | Participants will receive JNJ-70033093 dose BID for 8 days followed by a JNJ-70033093 dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. Receives: Drug: JNJ-70033093; Drug: Placebo |
| Part 1: Treatment D | Experimental | Participants will receive JNJ-70033093 dose BID for 8 days followed by a JNJ-70033093 dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. Receives: Drug: JNJ-70033093; Drug: Placebo |
| Part 2: Treatment Sequence EFG | Experimental | Participants will receive Treatment E (JNJ-7003309 single dose in the morning in fasted condition) in treatment Period 1; followed by Treatment F (JNJ-7003309 single dose administered in the evening in fasted condition) in treatment Period 2; followed by Treatment G (JNJ-7003309 single dose administered in the evening in fasted condition) in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period. Receives: Drug: JNJ-70033093 |
| Part 2: Treatment Sequence FGE | Experimental | Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period. Receives: Drug: JNJ-70033093 |
| Part 2: Treatment Sequence GEF | Experimental | Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period Receives: Drug: JNJ-70033093 |
| Part 2: Treatment Sequence EGF | Experimental | Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period Receives: Drug: JNJ-70033093 |
| Part 2: Treatment Sequence GFE | Experimental | Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period Receives: Drug: JNJ-70033093 |
| Part 2: Treatment Sequence FEG | Experimental | Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period Receives: Drug: JNJ-70033093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093
Cmax is the maximum observed analyte concentration.
Measured: Up to Day 9
Part 1: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of JNJ-70033093
Tmax is the actual sampling time to reach the maximum observed analyte concentration
Measured: Up to Day 9
Part 1: Area Under the Analyte Concentration-time Curve from Time Zero to 12 Hours (AUC[0-12h]) of JNJ-70033093
AUC(0-12h) is the area under the time-concentration curve (AUC) from time 0 (dosing time) to 12 hours before steady state.
Measured: 12 hours postdose (Day 1)
Part 1: Apparent Terminal Elimination Half-life (t[1/2]) of JNJ-70033093
T(1/2) is the apparent terminal elimination half-life is the time measured for the analyte concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Up to Day 9
Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093
Cmax is the maximum observed analyte concentration.
Measured: Up to Day 9
Part 2: Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-70033093
AUC (0-last) is area under the analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
Measured: Up to Day 9
Part 2: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-70033093
AUC (0-infinity) is the area under the analyte concentration-time curve (AUC) 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 plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant.
Measured: Up to Day 9
Secondary outcomes (7)
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 does not necessarily have a causal relationship with the treatment.
Measured: Up to 51 days
Number of Participants with Vital Sign Abnormalities
Number of participants with vital signs (including body temperature, resting [supine] pulse rate, and blood pressure) abnormalities will be reported.
Measured: Up to 51 days
Number of Participants with Abnormal Electrocardiogram (ECG) Findings
Number of participants with abnormal ECG findings will be reported.
Measured: Up to 51 days
Number of Participants with Abnormal Laboratory Findings
Number of participants with abnormal laboratory findings (that is, hematology, coagulation tests, clinical chemistry, urinalysis) will be reported.
Measured: Up to 51 days
Relationship Between JNJ-70033093 Plasma Concentrations and QTc After Multiple Doses of JNJ-70033093
Relationship between JNJ-70033093 plasma concentrations and QTc in healthy participants receiving multiple doses of JNJ-70033093 will be assessed.
Measured: Up to Day 9
Percentage Change from Baseline in Activated Partial Thromboplastin Time (aPTT)
aPTT measures the time to clot formation via the contact and common activation pathway. Blood will be collected for measurement of changes in aPTT clotting time.
Measured: Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2)
Percentage Change from Baseline in Factor XI Clotting Activity
Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay.
Measured: Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start10 Jan 2020
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT04223349
- Sponsor's protocol ID
- CR108728
- Other IDs
- 70033093THR1004
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Single-dose Crossover, and Double-blind Multiple-dose Parallel Group Study to Characterize the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of JNJ-70033093 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04223349
- Acronym / sponsor ID
- CR108728
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 10 Jan 2020 (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 purpose of this study is to characterize the pharmacokinetic (PK) of multiple twice-daily doses of JNJ-70033093 in healthy participants and to assess the effects of dosing time and food on the PK of single-dose of JNJ-70033093 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part 1: Treatment A | Experimental | Drug: JNJ-70033093, Drug: PlaceboParticipants will receive JNJ-70033093 dose twice daily (BID) for 8 days followed by a placebo dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. |
| Part 1: Treatment B | Experimental | Drug: JNJ-70033093, Drug: PlaceboParticipants will receive JNJ-70033093 dose BID for 8 days followed by a placebo dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. |
| Part 1: Treatment C | Experimental | Drug: JNJ-70033093, Drug: PlaceboParticipants will receive JNJ-70033093 dose BID for 8 days followed by a JNJ-70033093 dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. |
| Part 1: Treatment D | Experimental | Drug: JNJ-70033093, Drug: PlaceboParticipants will receive JNJ-70033093 dose BID for 8 days followed by a JNJ-70033093 dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. |
| Part 2: Treatment Sequence EFG | Experimental | Drug: JNJ-70033093Participants will receive Treatment E (JNJ-7003309 single dose in the morning in fasted condition) in treatment Period 1; followed by Treatment F (JNJ-7003309 single dose administered in the evening in fasted condition) in treatment Period 2; followed by Treatment G (JNJ-7003309 single dose administered in the evening in fasted condition) in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period. |
| Part 2: Treatment Sequence FGE | Experimental | Drug: JNJ-70033093Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period. |
| Part 2: Treatment Sequence GEF | Experimental | Drug: JNJ-70033093Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period |
| Part 2: Treatment Sequence EGF | Experimental | Drug: JNJ-70033093Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period |
| Part 2: Treatment Sequence GFE | Experimental | Drug: JNJ-70033093Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period |
| Part 2: Treatment Sequence FEG | Experimental | Drug: JNJ-70033093Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis performed at screening. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta-hCG]) at screening and urine (beta-hCG) pregnancy test on Day -1 of treatment period
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- Body mass index (BMI; weight kilogram per meter square [kg/m^2]) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kilogram (kg)
- After being supine for 10 minutes, systolic blood pressure between 90 and 140 millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood pressure
Key exclusion criteria (7 listed)
- If a woman, pregnant, breast-feeding or planning to become pregnant during the study
- History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to any known bleeding or clotting disorder, a history of arterial or venous thrombosis, liver or renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic abnormalities, metabolic disturbances, or poor venous access
- Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection at study screening
- History of, or a reason to believe a participant has a history of, drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM V) criteria within the past 1 year, which in the investigator's opinion would compromise participant safety and/or compliance with the study procedures
- History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation. History of allergy to or unwillingness to consume any component of the high-fat breakfast menu to be provided 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-70033093JNJ-70033093 capsules will be administered orally . | Drug | Part 1: Treatment A, Part 1: Treatment B, Part 1: Treatment C, Part 1: Treatment D, Part 2: Treatment Sequence EFG, Part 2: Treatment Sequence EGF, Part 2: Treatment Sequence FEG, Part 2: Treatment Sequence FGE, Part 2: Treatment Sequence GEF, Part 2: Treatment Sequence GFE |
| PlaceboMatching placebo in capsule will be administered orally. | Drug | Part 1: Treatment A, Part 1: Treatment B, Part 1: Treatment C, Part 1: Treatment D |
Primary outcome
Part 1: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093
Time frame: Up to Day 9
Cmax is the maximum observed analyte concentration.
Part 1: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of JNJ-70033093
Time frame: Up to Day 9
Tmax is the actual sampling time to reach the maximum observed analyte concentration
Part 1: Area Under the Analyte Concentration-time Curve from Time Zero to 12 Hours (AUC[0-12h]) of JNJ-70033093
Time frame: 12 hours postdose (Day 1)
AUC(0-12h) is the area under the time-concentration curve (AUC) from time 0 (dosing time) to 12 hours before steady state.
Part 1: Apparent Terminal Elimination Half-life (t[1/2]) of JNJ-70033093
Time frame: Up to Day 9
T(1/2) is the apparent terminal elimination half-life is the time measured for the analyte concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093
Time frame: Up to Day 9
Cmax is the maximum observed analyte concentration.
Part 2: Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-70033093
Time frame: Up to Day 9
AUC (0-last) is area under the analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
Part 2: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-70033093
Time frame: Up to Day 9
AUC (0-infinity) is the area under the analyte concentration-time curve (AUC) 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 plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant.
7 secondary outcomes
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 51 days
Number of Participants with Vital Sign Abnormalities
Time frame: Up to 51 days
Number of Participants with Abnormal Electrocardiogram (ECG) Findings
Time frame: Up to 51 days
Number of Participants with Abnormal Laboratory Findings
Time frame: Up to 51 days
Relationship Between JNJ-70033093 Plasma Concentrations and QTc After Multiple Doses of JNJ-70033093
Time frame: Up to Day 9
Percentage Change from Baseline in Activated Partial Thromboplastin Time (aPTT)
Time frame: Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2)
Percentage Change from Baseline in Factor XI Clotting Activity
Time frame: Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2)
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 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
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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-70033093 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 7 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 27 Apr 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 United States. 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: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093 (time frame: Up to Day 9). The study lists 7 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 27 Apr 2025.