Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-72537634 · 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. 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...
JNJ-72537634 is an investigational monoclonal antibody developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early clinical development.
JNJ-72537634 is being 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 antibody in healthy participants.
JNJ-72537634 is in Phase 1 development. Its only recorded clinical trial, NCT03931447, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA for any indication.
JNJ-72537634 has been evaluated in one clinical trial, NCT03931447, titled A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants. The Phase 1 trial was completed, enrolled 31 participants, was randomized, double blind, and controlled, and was conducted in Belgium.
The Phase 1 trial of JNJ-72537634, NCT03931447, was a randomized, double blind, controlled study of the monoclonal antibody in healthy volunteers. It enrolled 31 participants aged 18 years and older of all sexes and was conducted in Belgium. The study has been completed.