NCT03879278

Multiple Ascending Dose Study in Healthy Subjects

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of NPT189 in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Proclara Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a Phase 1, randomized, double-blind, single center, placebo-controlled, multiple ascending dose (MAD) study in a maximum of 3 cohorts of 8 healthy male and female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple IV doses of NPT189 or matching placebo.

Detailed description

This study is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability and PK study of NPT189 in healthy subjects. Three dose cohorts are planned each with a maximum of 8 subjects (6 active: 2 placebo) enrolled per cohort. Eligible subjects will be administered NPT189 by IV infusions at the dose specified for their cohort (i.e., 2 mg/kg, 5 mg/kg, and 12.5 mg/kg) or a matching placebo. Subjects will receive a total of 5 doses of NPT189, with doses administered at weekly intervals. Safety and tolerability will be assessed by analysis of adverse events (AEs), vital signs, electrocardiograms (ECG), laboratory and physical examinations. PK will be assessed by analysis of serum NPT189 concentrations.

Conditions

• Amyloidosis

Interventions

Type	Name	Description
DRUG	NPT189	NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis.

Timeline

• Start date: 2019-03-06
• Primary completion: 2019-06-27
• Completion: 2019-06-27
• First posted: 2019-03-18
• Last updated: 2019-08-19

Locations

1 site across 1 country: Netherlands