A randomized, 2-part, placebo controlled phase 1 study to evaluate safety, tolerability, pharmacokinetics and immunogenicity following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GBR 830 in adult healthy subjects
Completed
- Conditions
- autoimmune disease10003816
- Registration Number
- NL-OMON44196
- Lead Sponsor
- Glenmark Pharmaceuticals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
- healthy volunteers
- 18 - 65 years, inclusive
- BMI: 18.5 - 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 3 months before the start of this study. Subjects with a history of donating 1 unit of blood (450 mL) blood in the 3 months prior to IP administration or who intend to donate within 3 months of their last scheduled study visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Frequency and severity of treatment-emergent adverse events (TEAEs) and SAEs<br /><br>for each treatment, based on CTCAE, version 4.03<br /><br>- Number of DLTs during treatment</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Cmax, trough plasma concentration (Ctrough), time at which Cmax is observed<br /><br>(tmax), AUC to the end of the dosing period (AUC0-tau), AUC from time 0 to<br /><br>infinity (AUC0-*), and AUC from time 0 unitl the last measurable concentration<br /><br>(AUC (0-t)), terminal elimination half life (t*), volume of distribution,<br /><br>clearance, and accumulation ratio (Rac) as applicable<br /><br>- ADA formation.</p><br>