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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03990519 | A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants | PHASE1 | COMPLETED | 33 | — | — | Jun 24, 2019 | Feb 19, 2020 | Apr 27, 2025 | 1 | United States |
An 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.
| Arm | Type | Description |
|---|---|---|
| Cohort1: JNJ-2636682/Placebo | EXPERIMENTAL | Participants will receive single dose of JNJ-26366821 or placebo on Day 1. |
| Cohort 2: JNJ-26366821/Placebo | EXPERIMENTAL | Participants will receive single dose of JNJ-26366821 or placebo on Day 1. |
| Cohort 3: JNJ-26366821/Placebo | EXPERIMENTAL | Participants will receive single dose of JNJ-26366821 or placebo. The dose of JNJ-26366821 will be selected based on the safety, pharmacodynamics, and pharmacokinetics data from the previous Cohorts 1 and 2. |
| Name | Type | Description |
|---|---|---|
| JNJ-26366821 | DRUG | Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC). |
| Placebo | DRUG | Participants will receive sodium chloride injection as placebo on Day 1. |
Inclusion Criteria: * Overall good health, on the basis of full physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening * Body weight 50 - 100 kilogram (kg), body mass index (BMI) 18 - 30 kilogram per meter square (kg/m\^2), inclusive at screen...