A Single-Center, Phase I, Randomized, Double- Blind, Placebo-Controlled, First-In-Man Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Subcutaneous MSB0010841 (Anti-IL-17A/F Nanobody) in Healthy Male Subjects
Completed
- Conditions
- illness that occurs when the body tissues are attacked by its own immune system10003816
- Registration Number
- NL-OMON38778
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
Inclusion Criteria
healthy male subjects,
18 - 45 yrs, inclusive,
20.0 - 30.0 kg/m2, inclusive
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>Pharmacodynamics : Pharmacodynamics parameters<br /><br>Pharmacokinetics : Pharmacokinetic parameters<br /><br>Safety : TEAEs, local tolerability assessment, clinical laboratory and vital<br /><br>signs</p><br>
- Secondary Outcome Measures
Name Time Method <p>n/a</p><br>