Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03931447 | A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants | PHASE1 | COMPLETED | 31 | — | — | Apr 30, 2019 | Feb 10, 2020 | May 23, 2025 | 1 | Belgium |
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. TEAEs are adverse events (AEs) which will occur up to 24 Weeks that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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. TEAEs are AEs which will occur up to 26 Weeks that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of participants with abnormalities in vital signs, ECG and clinically significant laboratory findings will be reported.
Number of participants with abnormalities in vital signs, ECG and clinically significant laboratory findings will be reported.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: JNJ-72537634 Dose 1 or Placebo (Part 1 - SD) | EXPERIMENTAL | Each participant will receive pretreatment with oral antibiotic; followed by a single day (SD) study intervention of JNJ-72537634 at dose 1 or placebo after overnight fast on Day 1. |
| Cohort 2: JNJ-72537634 Dose 2 or Placebo (Part 1 - SD) | EXPERIMENTAL | Each participant will receive pretreatment with oral antibiotic; followed by a SD study intervention of JNJ-72537634 at dose 2 or placebo after overnight fast on Day 1. |
| Cohort 3: JNJ-72537634 Dose 1 or Placebo (Part 2 - MD) | EXPERIMENTAL | Each participant will receive pretreatment with oral antibiotic; followed by a multiple day (MD) study intervention of JNJ-72537634 at dose 1 or placebo after overnight fast on Day 1 for 14 consecutive days. |
| Cohort 4: JNJ-72537634 Dose 2 or Placebo (Part 2 - MD) | EXPERIMENTAL | Each participant will receive pretreatment with oral antibiotic; followed by a MD study intervention of JNJ-72537634 at dose 2 or placebo after overnight fast on Day 1 for 14 consecutive days. |
| Name | Type | Description |
|---|---|---|
| JNJ-72537634 | BIOLOGICAL | Participants in Cohort 1 and 3 will receive Dose 1 and participants in Cohort 2 and 4 will receive Dose 2 of JNJ-72537634 as oral capsule. |
| Placebo | BIOLOGICAL | Participants will receive matching placebo as oral capsule in all cohorts. |
Inclusion Criteria: * Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of at least 50 kilogram (kg) * Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram...