A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to investigate the safety, tolerablility, pharmacokinetics (including food and gender effect), and pharmacodynamics of LNP1955 in healthy subjects.
Completed
- Conditions
- Inflammatory disease conditionsrheumatoid arthritis.10003816
- Registration Number
- NL-OMON42416
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
Healthy volunteers
18-65 yrs, inclusive
BMI: 18.0-32.0 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>To assess the safety and tolerability of single and multiple ascending oral<br /><br>doses of LNP1955 in healthy subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the pharmacokinetics (PK) of single and multiple ascending oral doses<br /><br>of LNP1955 in healthy subjects.</p><br>