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This Phase 1b study will evaluate the safety of PRV-3279 in healthy adult subjects
PRV-3279-1b is a Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects.
Eligible subjects include healthy male or female adults, 18 to 50 years of age. Each subject will receive the assigned treatment over 29 days followed by a 56-day follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (PRV-3279 or placebo) | Experimental | Sterile solution for intravenous administration, 3 doses, every 2 weeks |
|
| Cohort B (PRV-3279 or placebo) | Experimental | Sterile solution for intravenous administration, 3 doses, every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRV-3279 or placebo | Biological | bi-specific antibody-based molecule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) | Assessment of safety and tolerability | 85 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Provention Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical site | Baltimore | Maryland | 21225 | United States |
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Double-blind, placebo-controlled, multiple ascending dose study
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