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JNJ-68179280 · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
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 clinically significant abnormalities in vital signs (including temperature \[oral or tympanic\], pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Number of participants with clinically significant abnormalities in physical examination (including general appearance, respiratory, cardiovascular, assessment through skin or oral mucosa) will be reported.
Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.
Number of participants with clinically significant abnormalities in ECGs will be reported.
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | EXPERIMENTAL | Participants will receive a single ascending oral dose of JNJ-68179280 or placebo capsules under fasted condition (Cohort 1, 2 and 5) and under fasted-fed condition (either Cohort 3 or 4) on Day 1. In 1 of the study cohorts 3 or 4, participants will also receive study intervention on Day 8 under fed condition. One additional optional Cohort 6 may be dosed to assess the safety and pharmacokinetics (PK) of an alternate dose of formulation A under fasted condition. |
| Part 2: Multiple Ascending Dose (MAD) | EXPERIMENTAL | Participants will receive multiple ascending oral doses of JNJ-68179280 or placebo capsules once daily in Cohort 1 through 4 or twice daily in Cohort 5 (optional) on Days 1 through 14 under fasted or fed condition. |
| Part 3: Multiple Dose Alternative Formulation (Optional) | EXPERIMENTAL | Participants will receive multiple oral doses of an alternative JNJ-68179280 formulation once daily in Cohort 1 and Cohort 2 (optional) on Days 1 through 14 under fasted or fed condition. Doses in Part 3 will depend on the safety, tolerability, PK and pharmacodynamics data from Part 1 and Part 2. |
| Name | Type | Description |
|---|---|---|
| JNJ-68179280 | DRUG | JNJ-68179280 will be administered as an oral capsule. |
| Placebo | OTHER | Matching placebo will be administered as an oral capsule. |
Inclusion Criteria: * Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents...
JNJ-68179280 is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other. One Phase 1 trial has been completed.
JNJ-68179280 is being studied for use in healthy participants. It is an investigational small molecule in Phase 1 clinical development. The completed trial evaluated the drug in healthy volunteers, but no specific disease indication has been reported for this asset.
JNJ-68179280 is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting clinical development of this investigational small molecule. The drug is currently in Phase 1 testing.
JNJ-68179280 is in Phase 1 clinical development. It is an investigational small molecule, and it has not been approved by regulatory authorities. One Phase 1 trial in healthy participants has been completed.
JNJ-68179280 has one completed Phase 1 trial, NCT04844463, titled "A Study of JNJ-68179280 in Healthy Participants." This trial enrolled 94 healthy volunteers in the United States, with participants aged 18 years and older. The study was randomized, double-blind, and controlled.
JNJ-68179280 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The drug has been studied in healthy participants in a completed trial, but it remains in clinical testing and has not received regulatory approval.