Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04667052 | A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants | PHASE1 | COMPLETED | 43 | — | — | Jan 13, 2021 | Jun 15, 2021 | Feb 3, 2025 | 1 | United States |
| NCT03002025 | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Participants | PHASE1 | COMPLETED | 48 | — | — | Jan 10, 2017 | Sep 9, 2017 | Feb 3, 2025 | 1 | Japan |
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...