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Multiple Ascending Dose Study in Healthy Subjects

NCT03879278 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-08-19

No results posted yet for this study

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.

Conditions

  • Amyloidosis

Interventions

DRUG

NPT189

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

Sponsors & Collaborators

  • Proclara Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Proclara Biosciences, Inc · Proclara Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2019-06-27
Completion
2019-06-27

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03879278 on ClinicalTrials.gov