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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03680105 | A Safety and Tolerability Study of RJX Drug Product in Healthy Participants | PHASE1 | COMPLETED | 76 | — | — | Aug 24, 2018 | Jan 15, 2019 | Apr 27, 2020 | 1 | United States |
Number of participants with indicated AEs receiving RJX as assessed by CTCAE v4 03
Number of participants with abnormal and clinically significant findings based on ECG.
Number of participants with clinically significant values and actual changes from baseline of continuous neurological assessments.
| Arm | Type | Description |
|---|---|---|
| Part 1; Cohort 1; RJX or Placebo | EXPERIMENTAL | Participants in Part 1; Cohort 1 will receive a single 0.024 mL/kg dose of RJX or matching placebo on Day 1. |
| Part 1; Cohort 2; RJX or Placebo | EXPERIMENTAL | Participants in Part 1; Cohort 2 will receive a single 0.076 mL/kg dose of RJX or matching placebo on Day 1. |
| Part 1; Cohort 3; RJX or Placebo | EXPERIMENTAL | Participants in Part 1; Cohort 3 will receive a single 0.240 mL/kg dose of RJX or matching placebo on Day 1. |
| Part 1; Cohort 4; RJX or Placebo | EXPERIMENTAL | Participants in Part 1; Cohort 4 will receive a single 0.5 mL/kg dose of RJX or matching placebo on Day 1. |
| Part 1; Cohort 5; RJX or Placebo | EXPERIMENTAL | Participants in Part 1; Cohort 5 will receive a single 0.759 mL/kg dose of RJX or matching placebo on Day 1. |
| Part 1; Cohort 6; RJX or Placebo | EXPERIMENTAL | Participants in Part 1; Cohort 6 will receive a single dose of RJX or matching placebo, to be determined following review of safety and PK data from Cohorts 1 to 5, on Day 1. |
| Part 2; Cohort 1; RJX or Placebo | EXPERIMENTAL | Participants in Part 2; Cohort 1 will receive a dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days. The Part 2; Cohort 1 dose will be 1 log down from the maximum tolerated dose determined in Part 1 or at a dose determined to be safe and well tolerated in Part 1 with an acceptable PK profile. |
| Part 2; Cohort 2; RJX or Placebo | EXPERIMENTAL | Participants in Part 2; Cohort 2 will receive an escalated dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days. |
| Part 2; Cohort 3; RJX or Placebo | EXPERIMENTAL | Participants in Part 2; Cohort 3 will receive an escalated dose of RJX or matching placebo, determined based on the findings of Part 1, every day for 7 days. |
| Name | Type | Description |
|---|---|---|
| RJX | DRUG | RJX is an IV infusion formulation. The appropriate RJX dose is calculated based on mL/kg. The administration dose is prepared by adding the appropriate RJX dose to 0.9% sterile saline such that a constant volume of 100 mL per IV infusion is obtained. Infusion time is 100 mL over 45 minutes (+/- 5 minutes). |
| Placebo | DRUG | Matching placebo will be normal saline. To maintain the blind, a sleeve will cover the infusion bag and line such that the appearance will be identical to RJX administration. |
Inclusion Criteria: 1. Healthy male and female participants aged 18 to 50 years inclusive (Cohort 1 to Cohort 5) or 51 to 70 years inclusive (Cohort 6 only),at the time of screening; 2. Have a body mass index of 18 kg/m2 to 35 kg/m2, inclusive, at screening. In addition, weight cannot exceed 132 kg...