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

Healthy Volunteers Clinical Trial

— MAS-FIH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665154
• Other study ID #: CMAS825A02101
• Status: Completed
• Phase: Phase 1
• Start date: June 7, 2019
• Est. completion date: August 3, 2022

Study information

• Verified date: September 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Mere Way	Nottingham
United States	Novartis Investigative Site	Overland Park	Kansas
United States	Novartis Investigative Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	To assess the safety and tolerability of single i.v./s.c. doses of MAS825	up to day 253
Secondary	Concentrations of anti-MAS825 antibodies	To assess immunogenicity (IG) of MAS825	up to day 197
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacokinetic parameters of MAS825: AUCinf	The AUC from time zero to infinity (mass x time x volume-1)	up to day 197
Secondary	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
Secondary	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
Secondary	Pharmacokinetic parameters of MAS825: Vz	Vz is the volume of distribution during the terminal elimination phase following intravenous administration [volume]	up to day 197
Secondary	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 ?z) (volume)	up to day 197
Secondary	Pharmacokinetic parameters of MAS825: Vss	Vss is the volume of distribution at steady state following intravenous administration [volume]	up to day 197
Secondary	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