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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503917-31 | EudraCT Number |
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The highest multiple dose planned for this study was not well tolerated by most participants. There is no benefit to continue dosing of healthy participants.
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The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants.
This is a single and multiple ascending dose, proof of concept study assessing the safe and tolerable dose of IRX-010 in healthy participants. Approximately 81 healthy participants will be enrolled in up to 9 cohorts. The study is conducted in two parts (part A and part B) with 6 single ascending dose (Part A - SAD) cohorts of 9 participants per cohort and 3 multiple ascending dose (Part B - MAD) cohorts of 9 participants per cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRX-010 Part A (SAD) | Experimental | A single dose of IRX-010 will be administered intravenously |
|
| Placebo Part A (SAD) | Placebo Comparator | Placebo administered intravenously |
|
| IRX-010 Part B(MAD) | Experimental | Multiple doses of IRX-010 will be administered intravenously |
|
| Placebo Part B(MAD) | Placebo Comparator | Placebo administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRX-010 | Drug | Administered IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Serious Adverse Events | Evaluation of Safety and Tolerability of IRX-010 | Baseline upto Day 168 |
| Number of participants with Treatment-Emergent Adverse Events | Evaluation of Safety and Tolerability of IRX-010 | Baseline upto Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(PK): Area under Curve(AUC) | PK: AUC of IRX-010 | Baseline upto Day 168 |
| Pharmacokinetics(PK): Maximum Concentration (Cmax) | PK: Cmax of IRX-010 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ImmunoRx Pharma,Inc | ImmunoRx Pharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Groningen | Provincie Groningen | 9728 | Netherlands |
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| Placebo |
| Drug |
Administered IV |
|
| Baseline upto Day 168 |
| Pharmacokinetics(PK): Half-Life (t½) | PK: t½ of IRX-010 | Baseline upto Day 168 |