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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 3, 2022

Interventions

  • Drug: MAS825
    • single dose i.v. and s.c.
  • Drug: Placebo
    • single dose i.v. and s.c.

Arms, Groups and Cohorts

  • Experimental: MAS825 dose A
    • single i.v. dose
  • Experimental: MAS825 dose B
    • single s.c. dose
  • Placebo Comparator: Placebo dose A
    • single i.v. dose
  • Placebo Comparator: Placebo dose B
    • single s.c. dose

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Concentrations of anti-MAS825 antibodies
    • Time Frame: up to day 197
    • To assess immunogenicity (IG) of MAS825
  • 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)
  • 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)
  • 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)
  • Pharmacokinetic parameters of MAS825: AUCinf
    • Time Frame: up to day 197
    • The AUC from time zero to infinity (mass x time x volume-1)
  • 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
  • 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]
  • 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]
  • 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)
  • Pharmacokinetic parameters of MAS825: Vss
    • Time Frame: up to day 197
    • Vss is the volume of distribution at steady state following intravenous administration [volume]
  • 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]

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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