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 being developed by Johnson & Johnson. It is currently in Phase 1 clinical development for use in healthy participants. The drug is being studied for safety and tolerability, and it is not yet approved by regulatory authorities.
The specific molecular target of JNJ-72537634 has not been disclosed in available information. As a monoclonal antibody, it is designed to bind to a specific protein, but the exact target is not publicly detailed at this time.
JNJ-72537634 is developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy participants.
JNJ-72537634 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The Phase 1 trial is designed to assess safety and tolerability in healthy volunteers.
JNJ-72537634 has one completed Phase 1 clinical trial, identified as NCT03931447. This study, titled "A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants," was conducted in Belgium with 31 healthy volunteers aged 18 years and older. The trial was randomized, double-blind, and controlled.