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The purpose of the study is to evaluate the safety and tolerability of single dose of NPT189 in healthy volunteers. The study will also evaluate the pharmacokinetic characteristics of NPT189.
This study is a Phase1, randomized, double-blind, placebo-controlled, single dose, dose escalation safety and tolerability study of NPT189 in health subjects. Six dose cohorts are planned each with a maximum of 8 participants per cohort. Participants will receive NPT189 by intravenous (IV) or a matching placebo by intravenous infusion. Safety, tolerability, and pharmacokinetics will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | NPT189 |
|
| Placebo Comparator | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPT189 | Drug | IgG1 Fc-GAIM fusion protein, a recombinant fusion protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of a single intravenous (IV) infusion of NPT189 (subjects experiencing adverse events) | Summary of the frequency and percentage of | Day 1 through to Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189 (Cmax) | Observed maximum concentration (Cmax) | Day 1 through to Day 49 |
| Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189 (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Proclara Biosciences | Proclara | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24768993 | Background | Krishnan R, Tsubery H, Proschitsky MY, Asp E, Lulu M, Gilead S, Gartner M, Waltho JP, Davis PJ, Hounslow AM, Kirschner DA, Inouye H, Myszka DG, Wright J, Solomon B, Fisher RA. A bacteriophage capsid protein provides a general amyloid interaction motif (GAIM) that binds and remodels misfolded protein assemblies. J Mol Biol. 2014 Jun 26;426(13):2500-19. doi: 10.1016/j.jmb.2014.04.015. Epub 2014 Apr 22. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 15, 2019 | |
| Reset | Sep 20, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 15, 2019 | Sep 20, 2019 |
| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Placebo | Drug | Placebo |
|
Time of the maximum measured concentration (Tmax)
| Day 1 through to Day 49 |
| Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189 (AUClast) | Area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast) | Day 1 through to Day 49 |
| Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189 (AUCinf) | Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | Day 1 through to Day 49 |
| Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189. Terminal elimination half-life (t 1/2) | Terminal elimination half-life (t 1/2) | Day 1 through to Day 49 |
| Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189. Clearance (CL) | Clearance (CL) | Day 1 through to Day 49 |
| Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189. Volume of distribution (Vd) | Apparent volume of distribution (Vd) | Day 1 through to Day 49 |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |