Healthy VolunteersPhase 1MAS-FIHNCT04665154
A First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers
A Phase 1 study testing MAS825 in people with Healthy Volunteers, run by Novartis Pharmaceuticals at 3 sites in 2 countries.
Trial summary
The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MAS825
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 7 Jun 2019to 3 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Novartis Investigative Site
Overland Park, Kansas, 66211
Novartis Investigative Site
Tempe, Arizona, 85283
United Kingdom1 site
Novartis Investigative Site
Mere Way, Nottingham, NG11 6JS
About this study
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
The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- MAS825, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAS825Drug
single dose i.v. and s.c.
PlaceboDrug
single dose i.v. and s.c.
| Study group | Role | What they receive |
|---|---|---|
| MAS825 dose A | Experimental | single i.v. dose Receives: Drug: MAS825 |
| MAS825 dose B | Experimental | single s.c. dose Receives: Drug: MAS825 |
| Placebo dose A | Placebo comparator | single i.v. dose Receives: Drug: Placebo |
| Placebo dose B | Placebo comparator | single s.c. dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
To assess the safety and tolerability of single i.v./s.c. doses of MAS825
Measured: up to day 253
Secondary outcomes (11)
Concentrations of anti-MAS825 antibodies
To assess immunogenicity (IG) of MAS825
Measured: 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)
Measured: 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)
Measured: 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)
Measured: up to day 197
Pharmacokinetic parameters of MAS825: AUCinf
The AUC from time zero to infinity (mass x time x volume-1)
Measured: 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
Measured: 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]
Measured: up to day 197
Pharmacokinetic parameters of MAS825: Vz
Vz is the volume of distribution during the terminal elimination phase following intravenous administration [volume]
Measured: 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)
Measured: up to day 197
Pharmacokinetic parameters of MAS825: Vss
Vss is the volume of distribution at steady state following intravenous administration [volume]
Measured: 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]
Measured: up to day 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start7 Jun 2019
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665154
- Sponsor's protocol ID
- CMAS825A02101
- Acronym
- MAS-FIH
- Status last verified
- Sep 2022
- First submitted
- 30 Nov 2020
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04665154
- Acronym / sponsor ID
- MAS-FIH / CMAS825A02101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MAS825 dose A | Experimental | Drug: MAS825single i.v. dose |
| MAS825 dose B | Experimental | Drug: MAS825single s.c. dose |
| Placebo dose A | Placebo comparator | Drug: Placebosingle i.v. dose |
| Placebo dose B | Placebo comparator | Drug: Placebosingle s.c. dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAS825single dose i.v. and s.c. | Drug | MAS825 dose A, MAS825 dose B |
| Placebosingle dose i.v. and s.c. | Drug | Placebo dose A, Placebo dose B |
Primary outcome
Number of Adverse Events
Time frame: up to day 253
To assess the safety and tolerability of single i.v./s.c. doses of MAS825
11 secondary outcomes
Concentrations of anti-MAS825 antibodies
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: Maximum Plasma Concentration [Cmax]
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: Time to reach maximum concentration [Tmax]
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: AUClast
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: AUCinf
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: T1/2
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: CL
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: Vz
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: Vz/F
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: Vss
Time frame: up to day 197
Pharmacokinetic parameters of MAS825: CL/F
Time frame: up to day 197
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: Yes. 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
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAS825 in people with Healthy Volunteers, run by Novartis Pharmaceuticals at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: up to day 253). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.