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The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAS825 dose A | Experimental | single i.v. dose |
|
| MAS825 dose B | Experimental | single s.c. dose |
|
| Placebo dose A | Placebo Comparator | single i.v. dose |
|
| Placebo dose B | Placebo Comparator | single s.c. dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAS825 | Drug | single dose i.v. and s.c. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | To assess the safety and tolerability of single i.v./s.c. doses of MAS825 | up to day 253 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of anti-MAS825 antibodies | To assess immunogenicity (IG) of MAS825 | up to day 197 |
| Pharmacokinetic parameters of MAS825: Maximum Plasma Concentration [Cmax] | Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1) |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Tempe | Arizona | 85283 | United States | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| Placebo |
| Drug |
single dose i.v. and s.c. |
|
| up to day 197 |
| Pharmacokinetic parameters of MAS825: Time to reach maximum concentration [Tmax] | Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time) | up to day 197 |
| Pharmacokinetic parameters of MAS825: AUClast | The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) | up to day 197 |
| Pharmacokinetic parameters of MAS825: AUCinf | The AUC from time zero to infinity (mass x time x volume-1) | up to day 197 |
| Pharmacokinetic parameters of MAS825: T1/2 | 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 | up to day 197 |
| Pharmacokinetic parameters of MAS825: CL | CL is the systemic (or total body) clearance from plasma (or serum or blood) following intravenous administration [volume / time] | up to day 197 |
| Pharmacokinetic parameters of MAS825: Vz | Vz is the volume of distribution during the terminal elimination phase following intravenous administration [volume] | up to day 197 |
| Pharmacokinetic parameters of MAS825: Vz/F | Vz/F is the apparent volume of distribution during the terminal elimination phase following s.c. administration (associated with λz) (volume) | up to day 197 |
| Pharmacokinetic parameters of MAS825: Vss | Vss is the volume of distribution at steady state following intravenous administration [volume] | up to day 197 |
| Pharmacokinetic parameters of MAS825: CL/F | CL/F is the apparent systemic (or total body) clearance from plasma (or serum or blood) following s.c. administration [volume / time] | up to day 197 |
| Overland Park |
| Kansas |
| 66211 |
| United States |
| Novartis Investigative Site | Mere Way | Nottingham | NG11 6JS | United Kingdom |