autoimmune disease
Conditions
Interventions
Part 1:
Group Day Treatment (mg/kg) How often
1 1 20 mg/kg GBR 830 or placebo Once
2 1 40 mg/kg GBR 830 or placebo Once
Part 2:
Group Day Treatment (mg/kg) How often
3 1, 8, 15, 22, 29 and 36 10 mg
autoimmune disease
Sponsors
Glenmark Pharmaceuticals SA
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - healthy volunteers - 18 - 65 years, inclusive - BMI: 18.5 - 32.0 kg/m2, inclusive
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Frequency and severity of treatment-emergent adverse events (TEAEs) and SAEs for each treatment, based on CTCAE, version 4.03 - Number of DLTs during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cmax, trough plasma concentration (Ctrough), time at which Cmax is observed (tmax), AUC to the end of the dosing period (AUC0-tau), AUC from time 0 to infinity (AUC0-*), and AUC from time 0 unitl the last measurable concentration (AUC (0-t)), terminal elimination half life (t*), volume of distribution, clearance, and accumulation ratio (Rac) as applicable - ADA formation. | — |
Countries
The Netherlands
Outcome results
None listed