A First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers

Study Overview
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Brief Summary
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The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.

Official Title
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A First-in-human, Randomized, Subject-blinded, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: MAS825
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAS825 dose A<br>single i.v. dose | Drug: MAS825<br>* single dose i.v. and s.c.<br>|
| Experimental: MAS825 dose B<br>single s.c. dose | Drug: MAS825<br>* single dose i.v. and s.c.<br>|
| Placebo Comparator: Placebo dose A<br>single i.v. dose | Drug: Placebo<br>* single dose i.v. and s.c.<br>|
| Placebo Comparator: Placebo dose B<br>single s.c. dose | Drug: Placebo<br>* single dose i.v. and s.c.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |