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MAS825 for Healthy Subjects (MAS-FIH Trial)

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• 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.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 253
Awards & highlights

MAS-FIH Trial Summary

This study is evaluating whether a drug may help treat cancer.

MAS-FIH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

MAS-FIH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 253
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 253 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Adverse Events
Secondary outcome measures
Concentrations of anti-MAS825 antibodies
Pharmacokinetic parameters of MAS825: AUCinf
Pharmacokinetic parameters of MAS825: AUClast
+8 more

Side effects data

From 2021 Phase 2 trial • 140 Patients • NCT04382651
16%
Acute respiratory failure
13%
Acute kidney injury
9%
Pneumonia bacterial
9%
Acute respiratory distress syndrome
7%
Hypotension
7%
Respiratory failure
7%
Hypoxia
6%
Atrial fibrillation
4%
Septic shock
4%
Anxiety
3%
Multiple organ dysfunction syndrome
3%
Cardiac arrest
3%
COVID-19 pneumonia
3%
COVID-19
3%
Sepsis
3%
Urinary tract infection
3%
Pancytopenia
1%
Metabolic acidosis
1%
Haemophagocytic lymphohistiocytosis
1%
Alanine aminotransferase increased
1%
Cardiac failure acute
1%
Fungaemia
1%
Cerebrovascular accident
1%
Distributive shock
1%
Respiratory arrest
1%
Nephropathy
1%
Acute coronary syndrome
1%
Cardiogenic shock
1%
Myocarditis
1%
Hypothermia
1%
Metabolic encephalopathy
1%
Pneumomediastinum
1%
Pneumothorax
1%
Pulmonary embolism
1%
Disseminated intravascular coagulation
1%
Pneumonia klebsiella
1%
Aspartate aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
MAS825 + SoC
Placebo + SoC
Total

MAS-FIH Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MAS825 dose BExperimental Treatment1 Intervention
single s.c. dose
Group II: MAS825 dose AExperimental Treatment1 Intervention
single i.v. dose
Group III: Placebo dose BPlacebo Group1 Intervention
single s.c. dose
Group IV: Placebo dose APlacebo Group1 Intervention
single i.v. dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MAS825
2019
Completed Phase 3
~230

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,273 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers
2019. "A First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04665154.
~14 spots leftby Apr 2025
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