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Completed

NCT Number: NCT04665154

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Mere Way, Nottingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MAS825

Drug

single dose i.v. and s.c.

Placebo

Drug

single dose i.v. and s.c.

Primary outcomes

  1. Number of Adverse Events

    Time frame: up to day 253

    To assess the safety and tolerability of single i.v./s.c. doses of MAS825

Secondary outcomes

  1. Concentrations of anti-MAS825 antibodies

    Time frame: up to day 197

    To assess immunogenicity (IG) of MAS825

  2. Pharmacokinetic parameters of MAS825: Maximum Plasma Concentration [Cmax]

    Time frame: up to day 197

    Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)

  3. Pharmacokinetic parameters of MAS825: Time to reach maximum concentration [Tmax]

    Time frame: up to day 197

    Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)

  4. Pharmacokinetic parameters of MAS825: AUClast

    Time frame: up to day 197

    The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)

  5. Pharmacokinetic parameters of MAS825: AUCinf

    Time frame: up to day 197

    The AUC from time zero to infinity (mass x time x volume-1)

  6. Pharmacokinetic parameters of MAS825: T1/2

    Time frame: up to day 197

    The elimination half-life associated with the terminal slope (lambda_z) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives

  7. Pharmacokinetic parameters of MAS825: CL

    Time frame: up to day 197

    CL is the systemic (or total body) clearance from plasma (or serum or blood) following intravenous administration [volume / time]

  8. Pharmacokinetic parameters of MAS825: Vz

    Time frame: up to day 197

    Vz is the volume of distribution during the terminal elimination phase following intravenous administration [volume]

  9. Pharmacokinetic parameters of MAS825: Vz/F

    Time frame: up to day 197

    Vz/F is the apparent volume of distribution during the terminal elimination phase following s.c. administration (associated with λz) (volume)

  10. Pharmacokinetic parameters of MAS825: Vss

    Time frame: up to day 197

    Vss is the volume of distribution at steady state following intravenous administration [volume]

  11. Pharmacokinetic parameters of MAS825: CL/F

    Time frame: up to day 197

    CL/F is the apparent systemic (or total body) clearance from plasma (or serum or blood) following s.c. administration [volume / time]

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A First-in-human, Randomized, Subject-blinded, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers

Acronym: MAS-FIH

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2020
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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