Teff-driven autoimmune and inflammatory diseases
Conditions
Interventions
MHS552, 2 different routes of administration
i.v. and s.c.
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy female and male 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 and/or baseline.
Exclusion criteria
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 - Receipt of live/attenuated vaccine within a 3-month period before first dose - Active, known, or suspected autoimmune disease or documented history of autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All safety endpoints (including physical examination findings, vital signs, ECG parameters, safety laboratory, adverse events) | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of MHS552 after i.v. and s.c. single doses such as Cmax, Tmax, AUClast, AUCinf, T1/2, Vz, CL and other PK parameters as appropriate | — |
Countries
Netherlands
Outcome results
None listed