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

Completed

• Conditions: Amyloïdose; Amyloidosis

• Registration Number: NL-OMON46311
• Lead Sponsor: Proclara Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

-Healthy male or female subjects
-18-65 yrs, inclusive
-BMI: 18-32 kg/m2, inclusive
-Weight >= 45kg and <= 120kg
-Non-smoking

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 a single IV infusion of NPT189.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the pharmacokinetics (PK) of a single IV infusion of NPT189.</p><br>