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 being developed by Johnson & Johnson. It is currently in Phase 1 clinical development, studied in healthy participants to evaluate its safety and tolerability. The drug is not approved and remains in clinical trials.
JNJ-67670187 is being studied in healthy participants to evaluate its safety and tolerability. It is an investigational monoclonal antibody in Phase 1 development, with no approved indication. The clinical trial focuses on healthy volunteers rather than a specific disease condition.
JNJ-67670187 is developed by Johnson & Johnson, a company traded under the ticker JNJ. The drug is an investigational monoclonal antibody currently in Phase 1 clinical development, studied in healthy participants.
JNJ-67670187 is in Phase 1 clinical development. It is an investigational monoclonal antibody being studied in healthy participants to evaluate safety and tolerability. The drug is not FDA approved and remains in clinical trials.
JNJ-67670187 has one completed Phase 1 clinical trial, identified as NCT03723746, titled "A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants." The trial enrolled 74 healthy participants in Belgium and the Netherlands.