A phase I randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics of NPT189 in healthy subjects
Completed
- Conditions
- AmyloïdoseAmyloidosis
- Registration Number
- NL-OMON48151
- Lead Sponsor
- Proclara Biosciences, Inc.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
- healthy males and females
- 18-65 years, inclusive
- Weight >= 45 kg and <= 120 kg with a BMI of 18.0-32.0 inclusive
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of
participation in another drug study within 90 days before the start of this
study or being a blood donor within 60 days from the start of the study. In
case of donating more than 1.5 liters of blood in the 10 months prior the start
of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To evaluate the safety and tolerability of repeated IV infusions of NPT189</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate the PK profile of NPT189 after repeated IV infusions</p><br>