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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-07

Study Completion Date

2022-08-03

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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MAS825 dose A

single i.v. dose

Group Type EXPERIMENTAL

MAS825

Intervention Type DRUG

single dose i.v. and s.c.

MAS825 dose B

single s.c. dose

Group Type EXPERIMENTAL

MAS825

Intervention Type DRUG

single dose i.v. and s.c.

Placebo dose A

single i.v. dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single dose i.v. and s.c.

Placebo dose B

single s.c. dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single dose i.v. and s.c.

Interventions

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MAS825

single dose i.v. and s.c.

Intervention Type DRUG

Placebo

single dose i.v. and s.c.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes