A PHASE 1, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL IN HEALTHY VOLUNTEERS TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING SINGLE AND MULTIPLE DOSES OF SNDX-6352 OR PLACEBO ADMINISTERED BY INTRAVENOUS (I.V.) INFUSIO
Completed
- Conditions
- Advanced cancer10027655
- Registration Number
- NL-OMON42865
- Lead Sponsor
- Syndax Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
Inclusion Criteria
Healthy males or females, 18-55 years old, inclusive, at screening. Body Mass Index (BMI): 19.0-30.0 kg/m2, inclusive. Weight: 50-100 kg, inclusive.
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, or HIV/AIDS. In case of participation in another drug study 60 days before the start of this study or being a blood donor within 60 days from the start of the study. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: Adverse events (AEs), clinical laboratory, vital signs, 12-lead<br /><br>electrocardiogram (ECG), presence of anti-drug antibodies (ADA) in plasma, eye<br /><br>examination, physical examination.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetics: Plasma SNDX-6352 concentrations and receptor occupancy (RO).<br /><br>Plasma PK parameters<br /><br><br /><br>Pharmacodynamics: Change in plasma CSF-1, IL-34, and CD-16 monocytes.</p><br>