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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: MAS825

• Registration Number: NCT04665154
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-07
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-11
• Primary Completion: 2022-08-03
• Study Completion: 2022-08-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo dose B	Placebo	single s.c. dose
Placebo dose A	Placebo	single i.v. dose
MAS825 dose A	MAS825	single i.v. dose
MAS825 dose B	MAS825	single s.c. dose

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
Concentrations of anti-MAS825 antibodies	up to day 197	To assess immunogenicity (IG) of MAS825
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)
Pharmacokinetic parameters of MAS825: AUCinf	up to day 197	The AUC from time zero to infinity (mass x time x volume-1)
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 \[volume / time\]
Pharmacokinetic parameters of MAS825: Vz	up to day 197	Vz is the volume of distribution during the terminal elimination phase following intravenous administration \[volume\]
Pharmacokinetic parameters of MAS825: Vss	up to day 197	Vss is the volume of distribution at steady state following intravenous administration \[volume\]
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
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)
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 \[volume / time\]

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Mere Way, Nottingham, United Kingdom