Status:
COMPLETED
A First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
June 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04665154
Start Date
June 7 2019
End Date
August 3 2022
Last Update
September 30 2022
Active Locations (3)
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1
Novartis Investigative Site
Tempe, Arizona, United States, 85283
2
Novartis Investigative Site
Overland Park, Kansas, United States, 66211
3
Novartis Investigative Site
Mere Way, Nottingham, United Kingdom, NG11 6JS