NCT04665154

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

3.2 years

First QC Date

November 30, 2020

Last Update Submit

September 29, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

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

    up to day 253

Secondary Outcomes (11)

  • Concentrations of anti-MAS825 antibodies

    up to day 197

  • Pharmacokinetic parameters of MAS825: Maximum Plasma Concentration [Cmax]

    up to day 197

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

    up to day 197

  • Pharmacokinetic parameters of MAS825: AUClast

    up to day 197

  • Pharmacokinetic parameters of MAS825: AUCinf

    up to day 197

  • +6 more secondary outcomes

Study Arms (4)

MAS825 dose A

EXPERIMENTAL

single i.v. dose

Drug: MAS825

MAS825 dose B

EXPERIMENTAL

single s.c. dose

Drug: MAS825

Placebo dose A

PLACEBO COMPARATOR

single i.v. dose

Drug: Placebo

Placebo dose B

PLACEBO COMPARATOR

single s.c. dose

Drug: Placebo

Interventions

MAS825DRUG

single dose i.v. and s.c.

MAS825 dose AMAS825 dose B
PlaceboDRUG

single dose i.v. and s.c.

Placebo dose APlacebo dose B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Tempe, Arizona, 85283, United States

Location

Novartis Investigative Site

Overland Park, Kansas, 66211, United States

Location

Novartis Investigative Site

Mere Way, Nottingham, NG11 6JS, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 11, 2020

Study Start

June 7, 2019

Primary Completion

August 3, 2022

Study Completion

August 3, 2022

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

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

Locations

GB(1)US(2)