HealthyPhase 1NCT03156738
A Clinical Study to Investigate How Safe and Tolerable the Study Drug MT-2990 is and How MT-2990 is Taken up by the Body in Healthy Volunteers
A Phase 1 study testing MT-2990 in people with Healthy, run by Tanabe Pharma Corporation at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT-2990
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 May 2017to 29 Dec 2017
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects are able and willing to provide written informed consent to participate in this study
- Healthy male subjects aged 18 to 55 years (inclusive)
- Free from clinically significant (CS) illness or disease
- Body weight of 60 to 100 kg (inclusive)
- Body mass index (Quetelet index) ranging from 18 to 30 kg/m2 (inclusive).
Who cannot join
- A CS endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological (including history of seizures), renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness or disorder (including anxiety, depression and reactive depression)
- Presence or history of any known malignancy with the exception of basal cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- A history of bacterial or viral infections that led to hospitalisation and IV antibiotic or antiviral treatment within 3 months prior to Screening, or any recent infection requiring antibiotic or antiviral treatment within 4 weeks of Day -1
- A history of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic infection is two episodes within 6 months)
- A history of tuberculosis (TB) or malaria; history or any evidence of active infection or febrile illness within 7 days of dosing (e.g., bronchopulmonary, urinary, or gastrointestinal)
- An active, or history of, parasitic infections; any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (e.g., history of splenectomy)
- Presence or history of severe adverse reaction or allergy to any drug or allergy that is of clinical significance to the Investigational Medicinal Product (IMP)
- A positive test result for QuantiFERON-TB Gold® Plus, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at Screening.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Pharmaceutical Research Associates (PRA) Health Sciences
NZ Groningen, 9728
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of MT-2990 in Healthy Male Subjects
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.
- Conditions
- Healthy
- Being tested
- MT-2990, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-2990Drug
Subjects will receive a single IV dose of MT-2990
PlaceboDrug
Subjects will receive a single IV dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | MT-2990 or Placebo Receives: Drug: MT-2990; Drug: Placebo |
| Dose 2 | Experimental | MT-2990 or Placebo Receives: Drug: MT-2990; Drug: Placebo |
| Dose 3 | Experimental | MT-2990 or Placebo Receives: Drug: MT-2990; Drug: Placebo |
| Dose 4 | Experimental | MT-2990 or Placebo Receives: Drug: MT-2990; Drug: Placebo |
| Dose 5 | Experimental | MT-2990 or Placebo Receives: Drug: MT-2990; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by incidence, nature and severity of adverse events
Adverse events will be summarised by dose level.
Measured: Up to Day 85
Safety and tolerability as measured by vital signs
Vital signs variables and changes from Baseline will be summarised by dose level.
Measured: Up to Day 85
Safety and tolerability as measured by ECG parameters
12-lead ECG variables and changes from Baseline will be summarised by dose level.
Measured: Up to Day 85
Safety and tolerability as measured by clinical laboratory assessments
Laboratory variables and changes from Baseline will be summarised by dose level.
Measured: Up to Day 85
Safety and tolerability as measured by physical examination
Physical examination data will be listed by subject.
Measured: Up to Day 85
Secondary outcomes (12)
Maximum observed serum concentration (Cmax) of MT-2990
Cmax will be summarised by dose level.
Measured: Up to Day 85
Measured time of maximum observed serum concentration (tmax) of MT-2990
tmax will be summarised by dose level.
Measured: Up to Day 85
Apparent terminal elimination half-life (t1/2) of MT-2990
t½ will be summarised by dose level.
Measured: Up to Day 85
AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990
AUC0-last will be summarised by dose level.
Measured: Up to Day 85
AUC from time zero to infinity (AUC0-∞) of MT-2990
AUC0-∞ will be summarised by dose level.
Measured: Up to Day 85
Terminal elimination rate constant (Kel) of MT-2990
Kel will be summarised by dose level.
Measured: Up to Day 85
Apparent volume of distribution at steady state (Vss) of MT-2990
Vss will be summarised by dose level.
Measured: Up to Day 85
Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990
Vz will be summarised by dose level.
Measured: Up to Day 85
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
MRT0-∞ will be summarised by dose level.
Measured: Up to Day 85
Apparent serum clearance (CL) of MT-2990
CL will be summarised by dose level.
Measured: Up to Day 85
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
%AUCex will be summarised by dose level.
Measured: Up to Day 85
Proportion of subjects who develop antibodies against MT-2990 in serum
The proportion of subjects who develop antibodies against MT 2990 in serum will be summarised using descriptive statistics on the Safety Analysis Set.
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start17 May 2017
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156738
- Sponsor's protocol ID
- MT-2990-E01
- Status last verified
- Jan 2018
- First submitted
- 15 May 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of MT-2990 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03156738
- Acronym / sponsor ID
- MT-2990-E01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 17 May 2017 (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 purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: MT-2990, Drug: PlaceboMT-2990 or Placebo |
| Dose 2 | Experimental | Drug: MT-2990, Drug: PlaceboMT-2990 or Placebo |
| Dose 3 | Experimental | Drug: MT-2990, Drug: PlaceboMT-2990 or Placebo |
| Dose 4 | Experimental | Drug: MT-2990, Drug: PlaceboMT-2990 or Placebo |
| Dose 5 | Experimental | Drug: MT-2990, Drug: PlaceboMT-2990 or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects are able and willing to provide written informed consent to participate in this study
- Healthy male subjects aged 18 to 55 years (inclusive)
- Free from clinically significant (CS) illness or disease
- Body weight of 60 to 100 kg (inclusive)
- Body mass index (Quetelet index) ranging from 18 to 30 kg/m2 (inclusive).
Key exclusion criteria (8 listed)
- A CS endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological (including history of seizures), renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness or disorder (including anxiety, depression and reactive depression)
- Presence or history of any known malignancy with the exception of basal cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- A history of bacterial or viral infections that led to hospitalisation and IV antibiotic or antiviral treatment within 3 months prior to Screening, or any recent infection requiring antibiotic or antiviral treatment within 4 weeks of Day -1
- A history of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic infection is two episodes within 6 months)
- A history of tuberculosis (TB) or malaria; history or any evidence of active infection or febrile illness within 7 days of dosing (e.g., bronchopulmonary, urinary, or gastrointestinal)
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 |
|---|---|---|
| MT-2990Subjects will receive a single IV dose of MT-2990 | Drug | Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 |
| PlaceboSubjects will receive a single IV dose of placebo | Drug | Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 |
Primary outcome
Safety and tolerability as measured by incidence, nature and severity of adverse events
Time frame: Up to Day 85
Adverse events will be summarised by dose level.
Safety and tolerability as measured by vital signs
Time frame: Up to Day 85
Vital signs variables and changes from Baseline will be summarised by dose level.
Safety and tolerability as measured by ECG parameters
Time frame: Up to Day 85
12-lead ECG variables and changes from Baseline will be summarised by dose level.
Safety and tolerability as measured by clinical laboratory assessments
Time frame: Up to Day 85
Laboratory variables and changes from Baseline will be summarised by dose level.
Safety and tolerability as measured by physical examination
Time frame: Up to Day 85
Physical examination data will be listed by subject.
12 secondary outcomes
Maximum observed serum concentration (Cmax) of MT-2990
Time frame: Up to Day 85
Measured time of maximum observed serum concentration (tmax) of MT-2990
Time frame: Up to Day 85
Apparent terminal elimination half-life (t1/2) of MT-2990
Time frame: Up to Day 85
AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990
Time frame: Up to Day 85
AUC from time zero to infinity (AUC0-∞) of MT-2990
Time frame: Up to Day 85
Terminal elimination rate constant (Kel) of MT-2990
Time frame: Up to Day 85
Apparent volume of distribution at steady state (Vss) of MT-2990
Time frame: Up to Day 85
Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990
Time frame: Up to Day 85
Mean residence time from time zero to infinity (MRT0-∞) of MT-2990
Time frame: Up to Day 85
Apparent serum clearance (CL) of MT-2990
Time frame: Up to Day 85
Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990
Time frame: Up to Day 85
Proportion of subjects who develop antibodies against MT-2990 in serum
Time frame: Up to Day 85
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 18 Jan 2018.
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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.
General Manager study director
Tanabe Pharma Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-2990 in people with Healthy, run by Tanabe Pharma Corporation at 1 site in Netherlands.
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 5 inclusion and 8 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. 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?
Safety and tolerability as measured by incidence, nature and severity of adverse events (time frame: Up to Day 85). The study lists 5 primary outcomes in all. 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 18 Jan 2018.