A phase I, single-centre, randomised, single-blinded, placebo-controlled single ascending dose study, followed by an open-label extension, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of ALX 0651, administered intravenously to healthy male volunteers.
Completed
- Conditions
- stamcel mobilisatiebeenmergbloedvormende stamcellen
- Registration Number
- NL-OMON35929
- Lead Sponsor
- Ablynx NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
Inclusion Criteria
- Healthy male volunteer
- Age between 18-55 years
- BMI between 19-29 kg/m2
- Only non-smokers
Exclusion Criteria
Suffering from: hepatitis B or C, 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 90 days from the start of the study or in case of donating more than 1.5 liter 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>safety and tolerability<br /><br>pharmacokinetics<br /><br>pharmacodynamics<br /><br>biologically effective dose (BED) and/or maximum tolerated dose (MTD)<br /><br>potential immunogenicity </p><br>
- Secondary Outcome Measures
Name Time Method <p>n/a</p><br>