A Phase 1 interventional study of MAS825 and Placebo in Healthy Volunteers, sponsored by Novartis Pharmaceuticals. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-30.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
single i.v. dose
Drug: MAS825
single s.c. dose
Drug: MAS825
single i.v. dose
Drug: Placebo
single s.c. dose
Drug: Placebo
single dose i.v. and s.c.
single dose i.v. and s.c.
Number of Adverse Events
To assess the safety and tolerability of single i.v./s.c. doses of MAS825
Time frame: up to day 253
Concentrations of anti-MAS825 antibodies
To assess immunogenicity (IG) of MAS825
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: AUCinf
The AUC from time zero to infinity (mass x time x volume-1)
Time frame: 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
Time frame: 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 \[volume / time\]
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: Vz
Vz is the volume of distribution during the terminal elimination phase following intravenous administration \[volume\]
Time frame: 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)
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: Vss
Vss is the volume of distribution at steady state following intravenous administration \[volume\]
Time frame: 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 \[volume / time\]
Time frame: up to day 197
Plan to share: Yes — 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
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals