A single centre, prospective, randomised, double-blind, placebo controlled, sequential, dose-escalating phase I study to assess the safety and tolerability of intravenously infused single doses of OPN-305 in healthy subjects.
Completed
- Conditions
- rejections10038365inflammatory reactions
- Registration Number
- NL-OMON38332
- Lead Sponsor
- Opsona Therapeutics Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Healthy male volunteers; 18 - 60 years; BMI 18.0 - 28.9 kg/m2; moderate or non-smoker.
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 90 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>Pharmacodynamics: antibodies concentrations, inflammatory cytokine levels, PD<br /><br>markers<br /><br>Pharmacokinetics: plasma OPN-305 concentrations, pharmacokinetic parameters<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>