Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-67670187 · 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 AEs which will occur between administration of study drug and 3 months or up to Day 84 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 between administration of study drug and 3 months or up to Day 98 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, physical examinations, ECG and clinically significant laboratory findings will be reported.
Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose 1 or Placebo (Part 1 - SD) | EXPERIMENTAL | Participants will receive a single oral dose (single day \[SD\] Dose 1) of either JNJ-67670187 or placebo capsules after an overnight fast on Day 1 of Part 1. |
| Cohort 2: Dose 2 or Placebo (Part 1 - SD) | EXPERIMENTAL | Participants will receive a single oral dose (Dose 2) of either JNJ-67670187 or placebo capsules after an overnight fast on Day 1 of Part 1. |
| Cohort 3: Dose 1 or Placebo (Part 2 - MD) | EXPERIMENTAL | Participants will receive an oral dose (Multiple Day \[MD\] Dose 1) of either JNJ-67670187 or placebo capsules once daily for 14 days without antibiotic pretreatment after an overnight fast in Part 2. |
| Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD) | EXPERIMENTAL | Participants will receive pretreatment with an oral antibiotic, followed by an oral dose (Dose 1) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. |
| Cohort 5: Dose 2 or Placebo (Part 2 - MD) | EXPERIMENTAL | Participants will receive an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily without antibiotic pretreatment for 14 days after an overnight fast in Part 2. |
| Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD) | EXPERIMENTAL | Participants will receive pretreatment with an oral antibiotic, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. |
| Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3) | EXPERIMENTAL | Participants may receive pretreatment with an oral laxative, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. Cohort 7 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2. |
| Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3) | EXPERIMENTAL | Participants may receive pretreatment with an oral antibiotic and oral laxative, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. Cohort 8 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2. |
| Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy | EXPERIMENTAL | Participants may receive an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. After final dosing collection of sigmoid biopsies will be performed. Cohort 9 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2. |
| Name | Type | Description |
|---|---|---|
| JNJ-67670187 | BIOLOGICAL | Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2. |
| Placebo | BIOLOGICAL | Participants will receive matching placebo in all cohorts. |
Inclusion Criteria: * Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) inclusive, and a body weight of at least 50 kilogram (kg) * Be otherwise healthy on the basis of physical examination, medical history, and vital signs, and 12 lead electrocardiogram (ECG) perfo...
JNJ-67670187 is an investigational monoclonal antibody developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy adult participants. No therapeutic indication for the drug has been disclosed, and it remains in early clinical development.
JNJ-67670187 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 antibody in healthy volunteers.
JNJ-67670187 is in Phase 1 development. Its only recorded clinical trial, NCT03723746, was a Phase 1 study that has been completed. The drug is investigational and is not approved for any use.
JNJ-67670187 has been evaluated in one clinical trial, NCT03723746, titled A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants. The Phase 1 trial enrolled 74 healthy adults in Belgium and the Netherlands and has been completed.
The Phase 1 trial NCT03723746 was a randomized, double-blind, controlled study of JNJ-67670187 in healthy volunteers aged 18 years and older. It enrolled 74 participants across sites in Belgium and the Netherlands and has been completed.