Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-55375515 Dose Level 1
JNJ-55375515 · 2 trials · 1 indication
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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.
The Tmax is defined as actual sampling time to reach maximum observed concentration.
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
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).
The Cmax is the maximum observed concentration.
The Tmax is defined as actual sampling time to reach maximum observed concentration.
The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
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).
The Cmax is the maximum observed concentration.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Panel 1): JNJ-55375515 and placebo | EXPERIMENTAL | Participants will receive dose level (DL) 1 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 3 (period 2) and a maximum of DL 5 (period 3) based on the safety and tolerability profile and pharmacodynamic (PD) profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations. |
| Part 1 (Panel 2): JNJ-55375515 and placebo | EXPERIMENTAL | Participants will receive DL 2 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 4 (period 2) and a maximum of DL 6 (period 3) based on the safety and tolerability profile and PD profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations. |
| Part 2: JNJ-55375515 and placebo | EXPERIMENTAL | Participants will randomly be assigned to one of four treatment sequences 1, 2, 3 or 4. In the first 3 sequences, participants will receive 2 doses of JNJ-55375515 and placebo. Participants assigned to sequence 4 will receive placebo only in all periods. 3 dose levels will be tested in Part 2 based on Part 1 and will not exceed those evaluated in Part 1. A wash-out period of at least 10 days will be maintained between study drug administrations in period 1, 2, 3 and 4. In period 4 (open-label pharmacokinetic (PK) assessment period) participants will be randomly assigned to one of two dose levels tested in periods 1 to 3. |
| Part 1: Single Ascending Dose (SAD) | EXPERIMENTAL | Participants will receive 0.75 milligrams (mg) of JNJ-55375515 (starting dose) or Placebo on Day 1. Dose of the study medication will be escalated sequentially up to a maximum of 200 mg. |
| Part 2: Multiple Ascending Dose (MAD) | EXPERIMENTAL | Participants will receive JNJ-55375515 (at doses determined based on the data from the SAD part) or Placebo from Day 1 to 10. |
| Name | Type | Description |
|---|---|---|
| JNJ-55375515 Dose Level 1 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study. |
| JNJ-55375515 Dose Level 2 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study. |
| JNJ-55375515 Dose Level 3 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study. |
| JNJ-55375515 Dose Level 4 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study. |
| JNJ-55375515 Dose Level 5 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study. |
| JNJ-55375515 Dose Level 6 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study. |
| Placebo | DRUG | All participants will receive matching placebo orally in Part 1 and Part 2 of the study. |
| JNJ-55375515 | DRUG | Participants will receive JNJ-55375515 as per the assigned treatment in Part 2. |
Inclusion Criteria: * Body Mass Index (BMI) between 18 and 30 kilogram / square meter (kg/m\^2) inclusive (BMI=weight/height\^2) * Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation or urinalysi...
JNJ-55375515 is an investigational small molecule developed by Johnson & Johnson. It has been studied in Phase 1 clinical trials in healthy participants to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics. The specific therapeutic indication for JNJ-55375515 has not been disclosed.
JNJ-55375515 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. Johnson & Johnson is the sponsor of the clinical trials evaluating this investigational small molecule.
JNJ-55375515 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
JNJ-55375515 has been evaluated in two completed Phase 1 trials. NCT03405441 studied safety, tolerability, pharmacokinetics, and pharmacodynamics in 42 healthy male participants in the Netherlands. NCT02623491 studied safety, tolerability, and pharmacokinetics in 175 healthy participants in Belgium. Both trials are completed.
JNJ-55375515 Dose Level 1 is an alternative name for JNJ-55375515. Both refer to the same investigational small molecule developed by Johnson & Johnson. The dose level designation distinguishes a specific dose cohort within the clinical program.