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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: MAS825; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Mere Way, Nottingham, United Kingdom, NG11 6JS
      • Novartis Investigative Site
• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Novartis Investigative Site
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	To assess the safety and tolerability of single i.v./s.c. doses of MAS825	up to day 253

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of anti-MAS825 antibodies	To assess immunogenicity (IG) of MAS825	up to day 197
Pharmacokinetic parameters of MAS825: Maximum Plasma Concentration [Cmax]	Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)	up to day 197
Pharmacokinetic parameters of MAS825: Time to reach maximum concentration [Tmax]	Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)	up to day 197
Pharmacokinetic parameters of MAS825: AUClast	The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)	up to day 197
Pharmacokinetic parameters of MAS825: AUCinf	The AUC from time zero to infinity (mass x time x volume-1)	up to day 197
Pharmacokinetic parameters of MAS825: T1/2	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	up to day 197
Pharmacokinetic parameters of MAS825: CL	CL is the systemic (or total body) clearance from plasma (or serum or blood) following intravenous administration [volume / time]	up to day 197
Pharmacokinetic parameters of MAS825: Vz	Vz is the volume of distribution during the terminal elimination phase following intravenous administration [volume]	up to day 197
Pharmacokinetic parameters of MAS825: Vz/F	Vz/F is the apparent volume of distribution during the terminal elimination phase following s.c. administration (associated with λz) (volume)	up to day 197
Pharmacokinetic parameters of MAS825: Vss	Vss is the volume of distribution at steady state following intravenous administration [volume]	up to day 197
Pharmacokinetic parameters of MAS825: CL/F	CL/F is the apparent systemic (or total body) clearance from plasma (or serum or blood) following s.c. administration [volume / time]	up to day 197

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2019
• Primary Completion (Actual): August 3, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CMAS825A02101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No