HealthyPhase 1NCT03151486
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Participants
A Phase 1 study testing JNJ-55308942 0.5 mg, JNJ-55308942 1.5 mg and JNJ-55308942 4 mg in people with Healthy, run by Janssen-Cilag International NV at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-55308942 in healthy participants after administration of single and multiple oral doses. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-55308942 0.5 mg, JNJ-55308942 1.5 mg and JNJ-55308942 4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteBelgium
- Study dates
- 3 May 2017to 8 Mar 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 18 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (BMI = weight [kg] / height [m]^2), and a body weight of not less than 50 kilogram (kg)
- Participant must be healthy on the basis of physical examination, neurological examination, medical history, vital signs, and 12 lead (electrocardiogram) ECG, and peripheral capillary oxygen saturation [(SpO2) greater than or equal to (>=) 97 percent] performed at Screening and Day -1
- 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, coagulation, hematology, 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. This determination must be recorded in the participant's source documents and initialed by the investigator
- Female participants must not be of childbearing potential by fulfilling 1 of the criteria: a) be over 45 years of age with no menses for 12 months without an alternative medical cause, with screening follicle stimulating hormone (FSH) levels of greater than (>) 40 International Unit per Liter (IU/L) or milli-International Unit per milliliter (mIU/mL). b) be permanently surgically sterile. Permanent surgical sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. Documentation of FSH levels is not required in the case of surgical sterility
- Female participants must have a negative serum pregnancy (Beta -human chorionic gonadotropin [Beta -hCG]) test at screening and a negative urine pregnancy test on Day -1
Who cannot join
- Participant has current, or history of, clinically significant medical illness including, but not limited to, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Participant has a history of abnormal bleeding or clotting, or disorder of fibrinogen (example, dysfibrinogenemia, hypofibrinogenemia)
- Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence)
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month or within a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug, or is currently enrolled in another investigational study
- Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, ecstasy, phencyclidine, tricyclic antidepressants, and benzodiazepines) at Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-55308942 in healthy participants after administration of single and multiple oral doses.
- Conditions
- Healthy
- Being tested
- JNJ-55308942 0.5 mg, JNJ-55308942 1.5 mg, JNJ-55308942 4 mg, JNJ-55308942 12 mg, JNJ-55308942 36 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-55308942 0.5 mgDrug
Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1.
JNJ-55308942 1.5 mgDrug
Participants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1.
JNJ-55308942 4 mgDrug
Participants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1.
JNJ-55308942 12 mgDrug
Participants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1.
JNJ-55308942 36 mgDrug
Participants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1.
JNJ-55308942 100 mgDrug
Participants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1.
JNJ-55308942: Fed StateDrug
Participants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts.
JNJ-55308942: MAD PartDrug
Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.
PlaceboDrug
Participants will receive matching placebo in all cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part) | Experimental | Participants will be randomized to receive a single dose of JNJ-55308942 0.5 milligrams (mg) or matching placebo as an oral solution after an overnight fast on Day 1 of Cohort 1 after single ascending dose (SAD). Receives: Drug: JNJ-55308942 0.5 mg; Drug: Placebo |
| Cohort 2: JNJ-55308942 1.5 mg or Placebo (SAD Part) | Experimental | Participants will be randomized to receive a single dose of JNJ-55308942 1.5 mg or matching placebo as an oral solution after an overnight fast on Day 1. Receives: Drug: JNJ-55308942 1.5 mg; Drug: Placebo |
| Cohort 3: JNJ-55308942 4 mg or Placebo (SAD Part) | Experimental | Participants will be randomized to receive a single dose of JNJ-55308942 4 mg or matching placebo as an oral solution after an overnight fast on Day 1. Receives: Drug: JNJ-55308942 4 mg; Drug: Placebo |
| Cohort 4: (JNJ-55308942 12 mg or Placebo (SAD Part)) | Experimental | Participants will be randomized to receive a single dose of JNJ-55308942 12 mg or matching placebo as an oral solution after an overnight fast on Day 1. Receives: Drug: JNJ-55308942 12 mg; Drug: Placebo |
| Cohort 5: JNJ-55308942 36 mg or Placebo (SAD Part) | Experimental | Participants will be randomized to receive a single dose of JNJ-55308942 36 mg or matching placebo as an oral solution after an overnight fast on Day 1. Receives: Drug: JNJ-55308942 36 mg; Drug: Placebo |
| Cohort 6: JNJ-55308942 100 mg or Placebo (SAD Part) | Experimental | Participants will be randomized to receive a single dose of JNJ-55308942 100 mg or matching placebo as an oral solution after an overnight fast on Day 1. Receives: Drug: JNJ-55308942 100 mg; Drug: Placebo |
| Cohort 7: JNJ-55308942 or Placebo (SAD Part) | Experimental | Participants will be randomized to receive a single dose of JNJ-55308942 or matching placebo as an oral solution in a fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts. Receives: Drug: JNJ-55308942: Fed State; Drug: Placebo |
| Cohort 1: JNJ-55308942 or Placebo (MAD Part) | Experimental | Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the multiple ascending doses (MAD) will be determined based on the data from the SAD part. Receives: Drug: JNJ-55308942: MAD Part; Drug: Placebo |
| Cohort 2: JNJ-55308942 or Placebo (MAD Part) | Experimental | Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part. Receives: Drug: JNJ-55308942: MAD Part; Drug: Placebo |
| Cohort 3: JNJ-55308942 or Placebo (MAD Part) | Experimental | Participants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part. Receives: Drug: JNJ-55308942: MAD Part; 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 (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Up to 6 Weeks
Single Ascending Dose (SAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
SAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
SAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942
AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1
SAD: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-Last]) of JNJ-55308942
AUC (0-last) is defined as area under the plasma JNJ-53308942 concentration-time curve from time 0 to time of the last observed quantifiable concentration.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
SAD: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-55308942
AUC (0-infinity) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to infinite time.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
SAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau)
AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
SAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942
The elimination half-life (T1/2) is the time measured for the plasma 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: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
Multiple Ascending Dose (MAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 on Day 1
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
Measured: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 on Day 1
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
Measured: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
MAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942 on Day 1
AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.
Measured: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1
MAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942 on Day 1
The elimination half-life (T1/2) is the time measured for the plasma 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: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
MAD: Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 After Dosing on Day 10
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
Measured: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 After Dosing on Day 10
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
Measured: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
MAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau) After Dosing on Day 10
AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.
Measured: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
MAD: Apparent Elimination Half-Life (t1/2) of JNJ-55308942 After Dosing on Day 10
The elimination half-life (T1/2) is the time measured for the plasma 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: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start3 May 2017
- Primary completion8 Mar 2018
- Study completion8 Mar 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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151486
- Sponsor's protocol ID
- CR108293
- Other IDs
- 2017-000303-25, 55308942EDI1001, 2017
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2017
- Last updated
- 27 Apr 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03151486
- Acronym / sponsor ID
- CR108293
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 3 May 2017 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 12 May 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 purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-55308942 in healthy participants after administration of single and multiple oral doses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part) | Experimental | Drug: JNJ-55308942 0.5 mg, Drug: PlaceboParticipants will be randomized to receive a single dose of JNJ-55308942 0.5 milligrams (mg) or matching placebo as an oral solution after an overnight fast on Day 1 of Cohort 1 after single ascending dose (SAD). |
| Cohort 2: JNJ-55308942 1.5 mg or Placebo (SAD Part) | Experimental | Drug: JNJ-55308942 1.5 mg, Drug: PlaceboParticipants will be randomized to receive a single dose of JNJ-55308942 1.5 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 3: JNJ-55308942 4 mg or Placebo (SAD Part) | Experimental | Drug: JNJ-55308942 4 mg, Drug: PlaceboParticipants will be randomized to receive a single dose of JNJ-55308942 4 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 4: (JNJ-55308942 12 mg or Placebo (SAD Part)) | Experimental | Drug: JNJ-55308942 12 mg, Drug: PlaceboParticipants will be randomized to receive a single dose of JNJ-55308942 12 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 5: JNJ-55308942 36 mg or Placebo (SAD Part) | Experimental | Drug: JNJ-55308942 36 mg, Drug: PlaceboParticipants will be randomized to receive a single dose of JNJ-55308942 36 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 6: JNJ-55308942 100 mg or Placebo (SAD Part) | Experimental | Drug: JNJ-55308942 100 mg, Drug: PlaceboParticipants will be randomized to receive a single dose of JNJ-55308942 100 mg or matching placebo as an oral solution after an overnight fast on Day 1. |
| Cohort 7: JNJ-55308942 or Placebo (SAD Part) | Experimental | Drug: JNJ-55308942: Fed State, Drug: PlaceboParticipants will be randomized to receive a single dose of JNJ-55308942 or matching placebo as an oral solution in a fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts. |
| Cohort 1: JNJ-55308942 or Placebo (MAD Part) | Experimental | Drug: JNJ-55308942: MAD Part, Drug: PlaceboParticipants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the multiple ascending doses (MAD) will be determined based on the data from the SAD part. |
| Cohort 2: JNJ-55308942 or Placebo (MAD Part) | Experimental | Drug: JNJ-55308942: MAD Part, Drug: PlaceboParticipants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part. |
| Cohort 3: JNJ-55308942 or Placebo (MAD Part) | Experimental | Drug: JNJ-55308942: MAD Part, Drug: PlaceboParticipants will be randomized to receive JNJ-55308942 or matching placebo once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part. |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (BMI = weight [kg] / height [m]^2), and a body weight of not less than 50 kilogram (kg)
- Participant must be healthy on the basis of physical examination, neurological examination, medical history, vital signs, and 12 lead (electrocardiogram) ECG, and peripheral capillary oxygen saturation [(SpO2) greater than or equal to (>=) 97 percent] performed at Screening and Day -1
- 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, coagulation, hematology, 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. This determination must be recorded in the participant's source documents and initialed by the investigator
- Female participants must not be of childbearing potential by fulfilling 1 of the criteria: a) be over 45 years of age with no menses for 12 months without an alternative medical cause, with screening follicle stimulating hormone (FSH) levels of greater than (>) 40 International Unit per Liter (IU/L) or milli-International Unit per milliliter (mIU/mL). b) be permanently surgically sterile. Permanent surgical sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. Documentation of FSH levels is not required in the case of surgical sterility
- Female participants must have a negative serum pregnancy (Beta -human chorionic gonadotropin [Beta -hCG]) test at screening and a negative urine pregnancy test on Day -1
Key exclusion criteria (5 listed)
- Participant has current, or history of, clinically significant medical illness including, but not limited to, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Participant has a history of abnormal bleeding or clotting, or disorder of fibrinogen (example, dysfibrinogenemia, hypofibrinogenemia)
- Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence)
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month or within a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug, or is currently enrolled in another investigational study
- Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before Screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines, ecstasy, phencyclidine, tricyclic antidepressants, and benzodiazepines) at Screening
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-55308942 0.5 mgParticipants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1. | Drug | Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part) |
| JNJ-55308942 1.5 mgParticipants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1. | Drug | Cohort 2: JNJ-55308942 1.5 mg or Placebo (SAD Part) |
| JNJ-55308942 4 mgParticipants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1. | Drug | Cohort 3: JNJ-55308942 4 mg or Placebo (SAD Part) |
| JNJ-55308942 12 mgParticipants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1. | Drug | Cohort 4: (JNJ-55308942 12 mg or Placebo (SAD Part)) |
| JNJ-55308942 36 mgParticipants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1. | Drug | Cohort 5: JNJ-55308942 36 mg or Placebo (SAD Part) |
| JNJ-55308942 100 mgParticipants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1. | Drug | Cohort 6: JNJ-55308942 100 mg or Placebo (SAD Part) |
| JNJ-55308942: Fed StateParticipants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts. | Drug | Cohort 7: JNJ-55308942 or Placebo (SAD Part) |
| JNJ-55308942: MAD PartParticipants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part. | Drug | Cohort 1: JNJ-55308942 or Placebo (MAD Part), Cohort 2: JNJ-55308942 or Placebo (MAD Part), Cohort 3: JNJ-55308942 or Placebo (MAD Part) |
| PlaceboParticipants will receive matching placebo in all cohorts. | Drug | Cohort 1: JNJ-55308942 or Placebo (MAD Part), Cohort 1:JNJ-55308942 0.5 mg or Placebo (SAD Part), Cohort 2: JNJ-55308942 1.5 mg or Placebo (SAD Part), Cohort 2: JNJ-55308942 or Placebo (MAD Part), Cohort 3: JNJ-55308942 4 mg or Placebo (SAD Part), Cohort 3: JNJ-55308942 or Placebo (MAD Part), Cohort 4: (JNJ-55308942 12 mg or Placebo (SAD Part)), Cohort 5: JNJ-55308942 36 mg or Placebo (SAD Part), Cohort 6: JNJ-55308942 100 mg or Placebo (SAD Part), Cohort 7: JNJ-55308942 or Placebo (SAD Part) |
Primary outcome
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 6 Weeks
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Single Ascending Dose (SAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
SAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
SAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1
AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.
SAD: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Observed Quantifiable Concentration (AUC [0-Last]) of JNJ-55308942
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
AUC (0-last) is defined as area under the plasma JNJ-53308942 concentration-time curve from time 0 to time of the last observed quantifiable concentration.
SAD: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-55308942
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
AUC (0-infinity) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to infinite time.
SAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau)
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.
SAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose on Day 1
The elimination half-life (T1/2) is the time measured for the plasma 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).
Multiple Ascending Dose (MAD): Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 on Day 1
Time frame: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 on Day 1
Time frame: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
MAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-55308942 on Day 1
Time frame: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1
AUC (0-24h) is defined as area under the plasma JNJ-55308942 concentration-time curve from time 0 to 24 hours postdose.
MAD: Apparent elimination Half-Life (t1/2) of JNJ-55308942 on Day 1
Time frame: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 16 hours postdose on Day 1
The elimination half-life (T1/2) is the time measured for the plasma 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).
MAD: Maximum Observed Plasma Concentration (Cmax) of JNJ-55308942 After Dosing on Day 10
Time frame: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
The Cmax is the maximum observed plasma concentration of JNJ-55308942.
MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-55308942 After Dosing on Day 10
Time frame: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
Tmax is defined as time to reach the maximum observed plasma JNJ-55308942 concentration.
MAD: Area Under the Plasma JNJ-55308942 Concentration-time Curve During a Dosing Interval (t) at steady-state (AUC tau) After Dosing on Day 10
Time frame: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
AUC tau is defined as area under the plasma JNJ-55308942 concentration-time curve during a dosing interval (tau) at steady-state.
MAD: Apparent Elimination Half-Life (t1/2) of JNJ-55308942 After Dosing on Day 10
Time frame: Predose, 0.25, 0.50, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 120 hours postdose on Day 10
The elimination half-life (T1/2) is the time measured for the plasma 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).
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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
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-55308942 0.5 mg, JNJ-55308942 1.5 mg and JNJ-55308942 4 mg in people with Healthy, run by Janssen-Cilag International NV 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 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 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 (AEs) as a Measure of Safety and Tolerability (time frame: Up to 6 Weeks). The study lists 16 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.