Double-blind, placebo-controlled, multiple ascending-dose study to investigate the safety and tolerability of AZ01 in healthy volunteers.

Completed

• Conditions: Multiple Sclerosis; 10003816

• Registration Number: NL-OMON36500
• Lead Sponsor: Allozyne, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Healthy men and women, 18 and 45 years of age, inclusive, BMI 18 and 30 kg/m2, max. 5 cigarettes smoking per day.

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 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 (for men) / more than 1.0 liters of blood (for women) 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>Pharmacokinetics:<br /><br>Plasma AZ01 concentrations, pharmacokinetic parameters.<br /><br><br /><br>Safety:<br /><br>Adverse events, vital signs, ECG-parameters, laboratory parameters, physical<br /><br>examination, TSH and antibodies to AZ01.<br /><br><br /><br>Pharmacodynamics:<br /><br>Plasma markers (neopterin), quantitative gene expression (MxA and OAS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>