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Also known as JNJ-42721458 (single dose)
JNJ-42721458 · 1 trial · 1 indication
Number of participants with adverse events will be used as a measure of safety and tolerability.
| Arm | Type | Description |
|---|---|---|
| Part 1: Panel 1 (0.1 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 0.1 mg of JNJ-42721458. |
| Part 1: Panel 2 (0.3 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 0.3 mg of JNJ-42721458. |
| Part 1: Panel 3 (1.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 1.0 mg of JNJ-42721458. |
| Part 1: Panel 4 (2.5 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 2.5 mg of JNJ-42721458. |
| Part 1: Panel 5 (5.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 5.0 mg of JNJ-42721458. |
| Part 1: Panel 6 (10.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 10.0 mg of JNJ-42721458. |
| Part 1: Panel 7 (20.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 20.0 mg of JNJ-42721458. |
| Part 1: Panel 8 | EXPERIMENTAL | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-7 in Part 1. |
| Part 1: Panel 9 | EXPERIMENTAL | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-8 in Part 1. |
| Part 1: Panel 10 | EXPERIMENTAL | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-9 in Part 1. |
| Part 1: Placebo | PLACEBO_COMPARATOR | 2 participants from each panel will receive a single dose of placebo. |
| Part 2: Panel 1 (5.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive multiple doses of 5.0 mg of JNJ-42721458. |
| Part 2: Panel 2 (10.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive multiple doses of 10.0 mg of JNJ-42721458. |
| Part 2: Panel 3 | EXPERIMENTAL | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-2 in Part 2. |
| Part 2: Panel 4 | EXPERIMENTAL | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-3 in Part 2. |
| Part 2: Panel 5 | EXPERIMENTAL | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-4 in Part 2. |
| Part 2: Panel 6 | EXPERIMENTAL | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-5 in Part 2. |
| Part 2: Placebo | PLACEBO_COMPARATOR | 2 participants from each panel will receive multiple doses of placebo. |
| Name | Type | Description |
|---|---|---|
| JNJ-42721458 (single dose) | DRUG | JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg. |
| JNJ-42721458 (multiple doses) | DRUG | JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg. |
| Placebo (single dose) | DRUG | Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1. |
| Placebo (multiple doses) | DRUG | Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2. |
Inclusion Criteria: * Body mass index (weight kg/m2) between 18 and 30 kg/m2, and body weight not less than 50 kg * Participant is judged to be generally in good health based on medical history, physical examination, vital signs and laboratory safety tests * Blood pressure between 90 and 135 mmHg s...
JNJ-42721458 is an investigational small molecule developed by Johnson & Johnson. It has been studied in a Phase 1 clinical trial in healthy male participants, and no therapeutic indication for the compound has been disclosed. It is not an approved medicine and remains in early clinical development.
JNJ-42721458 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 compound conducted in Belgium.
JNJ-42721458 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulator for any indication.
JNJ-42721458 has been evaluated in one completed Phase 1 trial, NCT01840501, titled a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JNJ-42721458 in healthy male participants. The trial enrolled 108 participants in Belgium and was randomized, double blind, and placebo controlled.
Yes. JNJ-42721458 (single dose) is an alternative name used for JNJ-42721458, referring to the same Johnson & Johnson investigational small molecule. Searches for either name point to the same compound and the same Phase 1 program.
The JNJ-42721458 Phase 1 trial, NCT01840501, was a randomized, double blind, placebo controlled study in healthy male volunteers aged 18 years and older. It enrolled 108 participants at sites in Belgium and assessed safety, tolerability, pharmacokinetics, and pharmacodynamics. The study is completed.