Healthy Volunteers
Conditions
Brief summary
The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.
Interventions
DRUGMAS825
single dose i.v. and s.c.
DRUGPlacebo
single dose i.v. and s.c.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy male and female subjects 18 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
Exclusion criteria
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant * A history of ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test * Fasting LDL \> 160 mg/dL, at screening. * Subjects in cohorts D1 and D2 (Japanese cohorts) must be of first to third generation Japanese ethnic origin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | up to day 253 | To assess the safety and tolerability of single i.v./s.c. doses of MAS825 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of MAS825: Maximum Plasma Concentration [Cmax] | up to day 197 | Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1) |
| Pharmacokinetic parameters of MAS825: Time to reach maximum concentration [Tmax] | up to day 197 | Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time) |
| Pharmacokinetic parameters of MAS825: AUClast | up to day 197 | The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) |
| Pharmacokinetic parameters of MAS825: AUCinf | up to day 197 | The AUC from time zero to infinity (mass x time x volume-1) |
| Pharmacokinetic parameters of MAS825: T1/2 | up to day 197 | The elimination half-life associated with the terminal slope (lambda\_z) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives |
| Concentrations of anti-MAS825 antibodies | up to day 197 | To assess immunogenicity (IG) of MAS825 |
| Pharmacokinetic parameters of MAS825: Vz | up to day 197 | Vz is the volume of distribution during the terminal elimination phase following intravenous administration \[volume\] |
| Pharmacokinetic parameters of MAS825: Vz/F | up to day 197 | Vz/F is the apparent volume of distribution during the terminal elimination phase following s.c. administration (associated with λz) (volume) |
| Pharmacokinetic parameters of MAS825: Vss | up to day 197 | Vss is the volume of distribution at steady state following intravenous administration \[volume\] |
| Pharmacokinetic parameters of MAS825: CL/F | up to day 197 | CL/F is the apparent systemic (or total body) clearance from plasma (or serum or blood) following s.c. administration \[volume / time\] |
| Pharmacokinetic parameters of MAS825: CL | up to day 197 | CL is the systemic (or total body) clearance from plasma (or serum or blood) following intravenous administration \[volume / time\] |
Countries
United Kingdom, United States
Outcome results
None listed