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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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This will be a randomized, double-blind, placebo-controlled, single- and multiple SC dose escalating study conducted in 2 parts.
A Phase 1, double-blind, randomized, placebo-controlled, single and multiple-dose escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB-718 following subcutaneous administration in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 | Experimental | PB-718 vs placebo |
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| Group A2 | Experimental | PB-718 vs placebo |
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| Group A3 | Experimental | PB-718 vs placebo |
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| Group A4 | Experimental | PB-718 vs placebo |
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| Group A5 | Experimental | PB-718 vs placebo |
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| Group A6 | Experimental | PB-718 vs placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | matching placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence, causality, and severity of AE. The condition of each subject will be monitored from the time of signing the ICF to Final Discharge from the study. Subjects will be observed for any signs or symptoms and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. Subjects will also be encouraged to spontaneously report AEs occurring at any other time during the study. | From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) profile | AUC (area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration) from time zero to the time of the last quantifiable concentration (AUC0-tlast) | From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Coleman, MD | Daytona Beach CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Daytona Beach | Florida | 32117 | United States |
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In Part A, 48 subjects will be studied in 6 groups (Groups A1 to A6), with each group consisting of 8 subjects.
In Part B, 32 subjects will be studied in 4 groups (Groups B1 to B4), with each group consisting of 8 subjects Following review of the safety, tolerability, and PK data, additional dose groups may be added to the study. Up to 3 further groups of 8 subjects (6 PB-718: 2 placebo) may be included in each of Parts A and B.
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The Investigator and other members of staff involved with the study will remain blinded to the treatment randomization code during the assembly procedure. The placebo solution will be identical in appearance to the PB-718.
| Group B1 |
| Experimental |
PB-718 vs placebo |
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| Group B2 | Experimental | PB-718 vs placebo |
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| Group B3 | Experimental | PB-718 vs placebo |
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| Group B4 | Experimental | PB-718 vs placebo |
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| PB 718 | Drug | dose in the next group will be determined following a review of data from the previous group |
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| Pharmacokinetic (PK) profile | Cmax (maximum observed plasma concentration) | From Group A1 until Group B4.The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks. |
| Pharmacokinetic (PK) profile | Tmax (time of the maximum observed plasma concentration) | From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks. |
| Pharmacokinetic (PK) profile | terminal disposition phase rate constant (λz) | From Group A1 until Group B4. The study duration for each subject in Part A will be approximately 8 weeks. The study duration for each subject in Part B will be approximately 11 weeks. |