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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04665154
Collaborator
(none)
80
3
4
37.9
26.7
0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
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 :
Jun 7, 2019
Anticipated Primary Completion Date :
Aug 4, 2022
Anticipated Study Completion Date :
Aug 4, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Number of Adverse Events [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 [up to day 197]

    To assess immunogenicity (IG) of MAS825

  2. Pharmacokinetic parameters of MAS825: Maximum Plasma Concentration [Cmax] [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] [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 [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 [up to day 197]

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

  6. Pharmacokinetic parameters of MAS825: T1/2 [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 [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 [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 [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 [up to day 197]

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

  11. Pharmacokinetic parameters of MAS825: CL/F [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

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Novartis Investigative Site Tempe Arizona United States 85283
2 Novartis Investigative Site Overland Park Kansas United States 66211
3 Novartis Investigative Site Mere Way Nottingham United Kingdom NG11 6JS

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04665154
Other Study ID Numbers:
  • CMAS825A02101
First Posted:
Dec 11, 2020
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 8, 2022