HealthyPhase 1NCT03346122
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
A Phase 1 study testing JNJ-64991524 Dose Level 1, JNJ-64991524 Dose Level 2 and JNJ-64991524 Dose Level 3 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-64991524 Dose Level 1, JNJ-64991524 Dose Level 2 and JNJ-64991524 Dose Level 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2017to 20 Nov 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)^2 to 30 kg/m^2, inclusive, at screening
- Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
- Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
- Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
- A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -2
Who cannot join
- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
- History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
- Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Has a history of or is infected with human immunodeficiency virus (HIV [positive serology for HIV antibody]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) at screening
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
Antwerp, 2060
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.
- Conditions
- Healthy
- Being tested
- JNJ-64991524 Dose Level 1, JNJ-64991524 Dose Level 2, JNJ-64991524 Dose Level 3, JNJ-64991524 Dose Level 4, JNJ-64991524 Dose Level 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64991524 Dose Level 1Drug
Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
JNJ-64991524 Dose Level 2Drug
Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
JNJ-64991524 Dose Level 3Drug
Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
JNJ-64991524 Dose Level 4Drug
Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
JNJ-64991524 Dose Level 5Drug
Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
JNJ-64991524 Dose Level 6Drug
Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
PlaceboDrug
Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
JNJ-64991524 Dose Level 7Drug
Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
JNJ-64991524 Dose Level 8Drug
Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
JNJ-64991524 Dose Level 9Drug
Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1) | Experimental | Participants will receive a single oral dose (Dose level 1) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. Receives: Drug: JNJ-64991524 Dose Level 1; Drug: Placebo |
| Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1) | Experimental | Participants will receive a single oral dose (Dose level 2) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. Receives: Drug: JNJ-64991524 Dose Level 2; Drug: Placebo |
| Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1) | Experimental | Participants will receive a single oral dose (Dose level 3) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. Receives: Drug: JNJ-64991524 Dose Level 3; Drug: Placebo |
| Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed) | Experimental | Participants will receive a single oral dose (Dose level 4) of either JNJ-64991524 or placebo capsules in a fasted condition on Day 1 and fed condition, on Day 7. Receives: Drug: JNJ-64991524 Dose Level 4; Drug: Placebo |
| Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1) | Experimental | Participants will receive a single oral dose (Dose level 5) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1. Receives: Drug: JNJ-64991524 Dose Level 5; Drug: Placebo |
| Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1) | Experimental | Participants will receive a single oral dose (Dose level 6) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1. Receives: Drug: JNJ-64991524 Dose Level 6; Drug: Placebo |
| Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2) | Experimental | Participants will receive an oral dose (Dose level 7) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and pharmacokinetics (PK) from Part 1. Receives: Drug: Placebo; Drug: JNJ-64991524 Dose Level 7 |
| Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2) | Experimental | Participants will receive an oral dose (Dose level 8) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1. Receives: Drug: Placebo; Drug: JNJ-64991524 Dose Level 8 |
| Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2) | Experimental | Participants will receive an oral dose (Dose level 9) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1. Receives: Drug: Placebo; Drug: JNJ-64991524 Dose Level 9 |
| Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2) | Experimental | Participants will receive an oral dose (Dose level 6) of JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined by tolerability and PK from Part 1. Receives: Drug: JNJ-64991524 Dose Level 6; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) 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. Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Up to Day 20
Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent 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. Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Up to Day 28
Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings
Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
Measured: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Secondary outcomes (1)
Plasma Concentration of JNJ-64991524
Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of JNJ-64991524.
Measured: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Nov 2017
- Primary completion20 Nov 2018
- Study completion20 Nov 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 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
- NCT03346122
- Sponsor's protocol ID
- CR108376
- Other IDs
- 2017-000229-11, 64991524EDI1001, 2017
- Status last verified
- Jan 2019
- First submitted
- 15 Nov 2017
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
- ClinicalTrials.gov ID
- NCT03346122
- Acronym / sponsor ID
- CR108376
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 17 Nov 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 evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.
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-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1) | Experimental | Drug: JNJ-64991524 Dose Level 1, Drug: PlaceboParticipants will receive a single oral dose (Dose level 1) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1) | Experimental | Drug: JNJ-64991524 Dose Level 2, Drug: PlaceboParticipants will receive a single oral dose (Dose level 2) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1) | Experimental | Drug: JNJ-64991524 Dose Level 3, Drug: PlaceboParticipants will receive a single oral dose (Dose level 3) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed) | Experimental | Drug: JNJ-64991524 Dose Level 4, Drug: PlaceboParticipants will receive a single oral dose (Dose level 4) of either JNJ-64991524 or placebo capsules in a fasted condition on Day 1 and fed condition, on Day 7. |
| Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1) | Experimental | Drug: JNJ-64991524 Dose Level 5, Drug: PlaceboParticipants will receive a single oral dose (Dose level 5) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1) | Experimental | Drug: JNJ-64991524 Dose Level 6, Drug: PlaceboParticipants will receive a single oral dose (Dose level 6) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2) | Experimental | Drug: Placebo, Drug: JNJ-64991524 Dose Level 7Participants will receive an oral dose (Dose level 7) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and pharmacokinetics (PK) from Part 1. |
| Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2) | Experimental | Drug: Placebo, Drug: JNJ-64991524 Dose Level 8Participants will receive an oral dose (Dose level 8) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1. |
| Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2) | Experimental | Drug: Placebo, Drug: JNJ-64991524 Dose Level 9Participants will receive an oral dose (Dose level 9) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1. |
| Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2) | Experimental | Drug: JNJ-64991524 Dose Level 6, Drug: PlaceboParticipants will receive an oral dose (Dose level 6) of JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined by tolerability and PK from Part 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Weigh at least 50 kilogram (kg), and have a body mass index (BMI) of 18 kg/ meter (m)^2 to 30 kg/m^2, inclusive, at screening
- Be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening and Day-1. This determination must be recorded in the participant's source documents and initialed by the investigator
- Be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, including liver enzymes, white blood cell count and hematocrit, coagulation, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and confirmed initialed by the investigator
- Have the platelet count pretreatment clinical laboratory values not below the normal range during Screening and Day -1
- A woman must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -2
Key exclusion criteria (5 listed)
- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Known allergies, hypersensitivity, or intolerance to JNJ-64991524 or its excipients
- History of severe allergic reaction, angioedema, or anaphylaxis to drugs or food
- Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Has a history of or is infected with human immunodeficiency virus (HIV [positive serology for HIV antibody]); tests positive for hepatitis B virus (HBV) infection; has antibodies to hepatitis C virus (HCV) 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-64991524 Dose Level 1Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study. | Drug | Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1) |
| JNJ-64991524 Dose Level 2Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study. | Drug | Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1) |
| JNJ-64991524 Dose Level 3Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study. | Drug | Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1) |
| JNJ-64991524 Dose Level 4Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study. | Drug | Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed) |
| JNJ-64991524 Dose Level 5Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study. | Drug | Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1) |
| JNJ-64991524 Dose Level 6Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study. | Drug | Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2), Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1) |
| PlaceboParticipants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study. | Drug | Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2), Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1), Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1), Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2), Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1), Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2), Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2), Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed), Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1), Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1) |
| JNJ-64991524 Dose Level 7Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days. | Drug | Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2) |
| JNJ-64991524 Dose Level 8Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days. | Drug | Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2) |
| JNJ-64991524 Dose Level 9Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days. | Drug | Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2) |
Primary outcome
Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to Day 20
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. Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.
Part 2: Multiple Ascending Dose (MAD): Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Day 28
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. Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), Cardiac Telemetry and Clinically Significant Laboratory Findings
Time frame: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
1 secondary outcome
Plasma Concentration of JNJ-64991524
Time frame: Pre-dose, up to Day 20 (SAD) and up to Day 28 (MAD)
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 24 Jan 2019.
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 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-64991524 Dose Level 1, JNJ-64991524 Dose Level 2 and JNJ-64991524 Dose Level 3 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. 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?
Part 1: Single Ascending Dose (SAD): Number of Participants with Treatment Emergent Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Up to Day 20). The study lists 3 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 24 Jan 2019.