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The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC4711 30mg | Experimental |
| |
| GC4711 60mg | Experimental |
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| GC4711 90mg | Experimental |
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| GC4711 120mg | Experimental |
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| Placebo | Placebo Comparator |
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| GC4711 75mg | Experimental |
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| GC4711 105mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC4711 30mg | Drug | single dose given via a 15 minute intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities | Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities | From randomization through study completion (estimated up to 3 days) |
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Inclusion Criteria:
Healthy men and women between 18 and 50 years
Subjects who provide written informed consent
Body Mass Index (BMI) of 18 to 32 kg/m2 and weighing at least 50 kg
Subjects in general good health
Blood pressure and pulse within normal limits
Male subjects must practice effective contraception
Female subjects must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Holmlund, MD | Galera Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | Australia |
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| GC4711 60mg |
| Drug |
single dose given via a 15 minute intravenous infusion |
|
| GC4711 90mg | Drug | single dose given via a 15 minute intravenous infusion |
|
| GC4711 120mg | Drug | single dose given via a 15 minute intravenous infusion |
|
| Placebo | Drug | single dose of normal saline given via a 15 minute intravenous infusion |
|
| GC4711 75mg | Drug | single dose given via a 15 minute intravenous infusion |
|
| GC4711 105mg | Drug | single dose given via a 15 minute intravenous infusion |
|