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

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: MAS825; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04665154

CMAS825A02101

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups, including a placebo group

MAS825 dose A

Experimental group

Description:

single i.v. dose

Treatment:

Drug: MAS825

MAS825 dose B

Experimental group

Description:

single s.c. dose

Treatment:

Drug: MAS825

Placebo dose A

Placebo Comparator group

Description:

single i.v. dose

Treatment:

Drug: Placebo

Placebo dose B

Placebo Comparator group

Description:

single s.c. dose

Treatment:

Drug: Placebo