Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ 64304500 · 2 trials · 1 indication
Cmax is the maximum observed serum concentration.
AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| JNJ 64304500: Reference | EXPERIMENTAL | Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 reference formulation. |
| JNJ 64304500: Test | EXPERIMENTAL | Participants (including individuals of Han Chinese background) will be randomized to receive a single subcutaneous dose of JNJ-64304500 test formulation. |
| Cohort 1: JNJ-64304500 50 milligram (mg) or placebo | EXPERIMENTAL | Participants (Japanese) will receive single subcutaneous (SC) dose of JNJ-64304500 50 mg or placebo on Day 1. |
| Cohort 2: JNJ-64304500 150 mg or placebo | EXPERIMENTAL | Participants (Japanese) will receive single SC dose of JNJ-64304500 150 mg or placebo on Day 1. |
| Cohort 3: JNJ-64304500 400 mg or placebo | EXPERIMENTAL | Participants (Japanese) will receive single SC dose of JNJ-64304500 400 mg or placebo on Day 1. |
| Cohort 4: JNJ-64304500 150 mg or placebo | EXPERIMENTAL | Participants (Caucasian) will receive single subcutaneous (SC) dose of JNJ-64304500 150 mg or placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| JNJ 64304500 | DRUG | Participants will receive a single subcutaneous dose of JNJ-64304500 reference formulation. |
| JNJ-64304500 | DRUG | Participants will receive JNJ-64304500 as SC injection. |
| Placebo | DRUG | Participants will receive matching placebo to JNJ-64304500 as SC injection. |
Inclusion criteria: * Male or non-childbearing potential female (according to their reproductive organs and functions assigned by chromosomal complement) * For Han Chinese participants, they need to have resided outside of China for no more than 10 years and have parents and maternal and paternal g...
JNJ 64304500 is an investigational small molecule being studied for the treatment of moderately to severely active Crohn's disease. It has also been evaluated in healthy participants to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is administered via subcutaneous injection and is currently in clinical development.
JNJ 64304500 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company has sponsored clinical trials investigating the drug for Crohn's disease and in healthy volunteers.
JNJ 64304500 is in Phase 1 clinical development. While one completed trial was registered as Phase 2, the overall development program includes Phase 1 studies. The drug is investigational and has not been approved by regulatory authorities. All trials listed for this asset have been completed.
JNJ 64304500 has been studied in three completed clinical trials. NCT02877134 evaluated the drug in 388 participants with moderately to severely active Crohn's disease across multiple countries. NCT03002025 and NCT04667052 assessed safety and formulation in healthy participants, with enrollments of 48 and 43 respectively.
Yes, JNJ 64304500 and JNJ-64304500 refer to the same investigational drug. The hyphenated version appears in clinical trial titles and registration records, while the non-hyphenated form is commonly used in shorthand. Both names denote the same small molecule being developed by Johnson & Johnson.
JNJ 64304500 is administered via subcutaneous injection, as indicated in clinical trial records. Studies have investigated different subcutaneous formulations of the drug in healthy participants. The administration route is consistent across the development program for this investigational small molecule.