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

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ClinicalTrials.gov Identifier: NCT04665154
Recruitment Status : Active, not recruiting
First Posted : December 11, 2020
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: MAS825 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : August 4, 2022
Estimated Study Completion Date : August 4, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: MAS825 dose A
single i.v. dose
 Drug: MAS825
single dose i.v. and s.c.
Experimental: MAS825 dose B
single s.c. dose
 Drug: MAS825
single dose i.v. and s.c.
Placebo Comparator: Placebo dose A
single i.v. dose
 Drug: Placebo
single dose i.v. and s.c.
Placebo Comparator: Placebo dose B
single s.c. dose
 Drug: Placebo
single dose i.v. and s.c.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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]


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665154


Locations
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United States, Arizona
Novartis Investigative Site
Tempe, Arizona, United States, 85283
United States, Kansas
Novartis Investigative Site
Overland Park, Kansas, United States, 66211
United Kingdom
Novartis Investigative Site
Mere Way, Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04665154    
Other Study ID Numbers: CMAS825A02101
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No