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Cohorts 1 and 2 were completed. Cohort 3 was cancelled because it was no longer necessary based on information from another study. No safety concerns were noted.
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This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMG-007 Cohort 1 (Healthy Participant) | Experimental | Cohort 1 will receive a single subcutaneous dose of IMG-007 Dose 1 or matching placebo. |
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| IMG-007 Cohort 2 (Healthy Participant) | Experimental | Cohort 2 will receive a single subcutaneous dose of IMG-007 Dose 2 or matching placebo. |
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| IMG-007 Cohort 3 (Healthy Participant) | Experimental | Cohort 3 will receive a single subcutaneous dose of IMG-007 Dose 3 or matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMG-007 | Drug | Subcutaneous injection of IMG-007 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Evaluation | Incidence of adverse events emergent from a single subcutaneous dose of IMG-007 in healthy participants. | Up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters, Cmax | Peak serum concentration following the administration of a single subcutaneous dose of IMG-007 | Up to 18 weeks |
| Pharmacokinetic Parameters, Tmax | Time to peak serum concentration following the administration of a single subcutaneous dose of IMG-007 |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Perth | Australia |
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| Placebo | Drug | Subcutaneous Injection of Placebo |
|
| Up to 18 weeks |
| Pharmacokinetic Parameters, AUC0-t | Area under the concentration-time curve from time 0 until the last observed concentration following the administration of a single subcutaneous dose of IMG-007 | Up to 18 weeks |