A first-in-human, randomized, dose-Escalation, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics of APX001 administered by intravenous infusion to healthy subjects.
Completed
- Conditions
- Fungal diseases.10003816
- Registration Number
- NL-OMON46244
- Lead Sponsor
- Amplyx Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Healthy male or female volunteers
18 - 55 years, inclusive
BMI 18.0 - 30.0 kilogram/meter2
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, tolerability, and pharmacokinetics of single and<br /><br>multiple doses of APX001 administered by intravenous infusion in healthy<br /><br>volunteers.<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Determine the maximum tolerated dose.<br /><br>2. Explore the APX001 safety profile in relation to the duration of infusion<br /><br>observed at APX001A target plasma exposures (AUC24) required for clinical<br /><br>efficacy.<br /><br>3. Explore the APX001 dose and dose regimen required to attain APX001A target<br /><br>plasma exposures (AUC24) required for clinical efficacy against Candida,<br /><br>Aspergillus and the hard-to-treat rare Molds (Scedosporium, Fusarium and<br /><br>Mucorales) invasive fungal infections.</p><br>