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Also known as JNJ-64991524 Dose Level 1
JNJ-64991524 · 1 trial · 1 indication
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.
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, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-64991524 Dose Level 1 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 2 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 3 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 4 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 5 | DRUG | Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 6 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study. |
| Placebo | DRUG | Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study. |
| JNJ-64991524 Dose Level 7 | DRUG | 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 8 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days. |
| JNJ-64991524 Dose Level 9 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days. |
Inclusion Criteria: * 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 det...
JNJ-64991524 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy adult participants in Belgium. The compound is also referred to as JNJ-64991524 Dose Level 1. Its therapeutic indication has not been disclosed.
JNJ-64991524 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound in healthy participants.
JNJ-64991524 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled 86 healthy participants and was randomized, double-blind, and controlled.
JNJ-64991524 has been evaluated in one completed Phase 1 trial, NCT03346122, titled A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants. The trial enrolled 86 healthy adults in Belgium and has completed.
Yes, JNJ-64991524 Dose Level 1 is an alternative name for JNJ-64991524. Both names refer to the same investigational small molecule developed by Johnson & Johnson, so searches using either name point to the same compound.