NL-OMON49201
Completed
Not Applicable
A first-in-human, randomized, subject-blinded, placebocontrolled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of MHS552 in healthy volunteers - A FIH study to investigate the safety, tolerability and PK of MHS552
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis
- Enrollment
- 64
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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