A first-in-human, randomized, subject-blinded, placebocontrolled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of MHS552 in healthy volunteers
Completed
- Conditions
- Teff-driven autoimmune and inflammatory diseases10003816
- Registration Number
- NL-OMON49201
- Lead Sponsor
- ovartis
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>All safety endpoints (including physical examination findings, vital signs, ECG<br /><br>parameters, safety laboratory, adverse events)</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK parameters of MHS552 after i.v. and s.c. single doses such as Cmax, Tmax,<br /><br>AUClast, AUCinf, T1/2, Vz, CL and other PK parameters as appropriate</p><br>