EVALUATION OF SAFETY, TOLERABILITY AND PHARMACOKINETIC CHARACTERISTICS OF MULTIPLE-ASCENDING DOSES OF CG400549 IN HEALTHY VOLUNTEERS
Completed
- Conditions
- MRSA10004018
- Registration Number
- NL-OMON34490
- Lead Sponsor
- Crystal Genomics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Sex: male
Age: 18-55 years, inclusive
BMI: 19-30 kg/m2
No relevant deviations at screening
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 (50 mL or more) 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 preceding the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics: plasma and urine CG400549 concentrations, pharmacokinetic<br /><br>parameters<br /><br><br /><br>Safety : adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination, </p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>