Healthy VolunteersPhase 1NCT02354599
Single-Dose Study of MT203
A Phase 1 study of Healthy Volunteers, run by Takeda at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male participants. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2014to May 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form and any required privacy authorizations prior to the initiation of any study procedures.
- The participant is a healthy adult male of Japanese or Caucasian (born to Caucasian parents and grandparents).
- The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
- The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m2) (for Japanese) or between 18.5 and 30.0 kg/m2 (for Caucasian), inclusive at screening and Day-1.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks (126 days) after last dose.
Who cannot join
- The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study medication.
- The participant has received MT203 or other anti-granulocyte-macrophage colony stimulating factor (GM-CSF) drugs in a previous clinical study.
- The participant has been vaccinated within 4 weeks (28 days) prior to the first dose of study medication or is scheduled to be vaccinated during the study.
- The participant is an immediate family member, study site employee or may consent under duress.
- The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormalities, which may impact the ability of the participant to participate or potentially confound the study results.
- History of frequent or chronic infections or herpes zoster.
Show all 21Show fewer
- The participant has a history of or currently has significant pulmonary disease, inflammatory disease or autoimmune disease.
- The participant has a known hypersensitivity to any component of the formulation of MT203.
- The participant has a positive urine drug result for drugs of abuse at screening. 10. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- 11. The participant has taken or requires excluded medications, supplements or food products listed in the Excluded Medications section throughout the study.
- 12. The participant intends to donate sperm during the course of this study or for 18 weeks after the last dose of study medication.
- 13. The participant has a history of cancer. 14. Presence, suspicion or history of active tuberculosis (TB) or latent TB infection.
- 15. The participant has a positive test result for hepatitis B virus (HBV) surface antigen (HBsAg), hepatitis B virus antibody (HBV surface virus antibody [HBsAb]/ HBV core antibody [HBcAb]), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening. However, participants who are positive for HBsAb due to HBV vaccination are exempt.
- 16. The participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 4 weeks (28 days) prior to the first dose of study medication.
- 17. The participant has clinically relevant decreased lung function, example, forced expiratory volume in the first second (FEV1) less than (<) 70 percent (%) of the predicted value.
- 18. The participant has poor peripheral venous access. 19. The participant has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the first dose of study medication.
- 20. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the first dose of study medication.
- 21. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study medication administration.
- 22. Participant has an abnormal (clinically significant) electrocardiogram (ECG) at screening or Day 1.
- 23. The participant has abnormal laboratory values at screening or Day-1 that suggest a clinically significant underlying disease or participant with the following laboratory abnormalities: Alanine transaminase (ALT) and/or aspartate transaminase (AST) greater than (>) 1.5 times the upper limit of normal or neutrophil counts and/or monocyte counts < the lower limit of normal.
- 24. Participant who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for the study with any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-center, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate Safety and Pharmacokinetics of Single Subcutaneous Injection of MT203 in Healthy Adult Japanese and Caucasian Male Participants
The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male participants.
Read the detailed description
The drug being tested in this study is called MT203 (Namilumab), which is a human immunoglobulin G1 (IgG1) mAb potently and specifically neutralizing human and macaque granulocyte macrophage colony stimulating factor (GM-CSF). This study will consist of Cohorts 1 to 3 for healthy Japanese participants and Cohort 4 for healthy Caucasian participants. Each cohort will be comprised of 8 participants, of whom 6 participants will be randomized to receive MT203 and 2 participants will be randomized to receive matched placebo.
The study population for the study will consist of 24 Japanese and 8 Caucasian healthy participants. Participants will be assigned to 4 cohorts which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need)::
Cohort 1:- MT203 80 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 2:- MT203 150 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 3:- MT203 300 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 4:- MT203 150 mg (6 healthy Caucasian participants); Matching Placebo (2 healthy Caucasian participants).
Dosing of the Caucasian participants (Cohort 4) may occur in parallel with dosing in Japanese participants (Cohorts 1 to 3). Dose escalation will occur in Japanese Cohorts, independent from Cohort 4. The dose escalation will only occur following a review of the blinded safety/tolerability data up to Day 15 from the previous cohort. All participants will receive a single dose on Day 1, admitted from Day -1 to Day 15. Participants will return to the study unit for the pharmacokinetic, pharmacodynamic and safety assessment on Days 22, 29, 43, 57, 71 and 85.
This trial will be conducted in Japan.Overall time to participate in this trial is 85 days.
- Conditions
- Healthy Volunteers
- Being tested
- MT203 80 mg or matching Placebo, MT203 150mg or matching Placebo, MT203 300 mg or matching placebo
- Keywords
- Randomized, double-blind, placebo-controlled, single-dose subcutaneous administration study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT203 80 mg or matching PlaceboDrug
Also called Namilumab, Placebo
MT203 80 mg or matching placebo injection
MT203 150mg or matching PlaceboDrug
Also called Namilumab, Placebo
MT203 150mg or matching placebo injection
MT203 300 mg or matching placeboDrug
Also called Namilumab, Placebo
MT203 300 mg or matching placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: MT203 80 mg | Experimental | Six Japanese participants will be randomized to receive a single dose of MT203 80 mg and 2 participants will be randomized to receive matched placebo subcutaneously. Receives: Drug: MT203 80 mg or matching Placebo |
| Cohort 1: MT203 80 mg matching placebo | Placebo comparator | Six Japanese participants will be randomized to receive a single dose of MT203 80 mg and 2 participants will be randomized to receive matched placebo subcutaneously. Receives: Drug: MT203 80 mg or matching Placebo |
| Cohort 2: MT203 150 mg | Experimental | Six Japanese participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. Receives: Drug: MT203 150mg or matching Placebo |
| Cohort 2: MT203 150 mg matching placebo | Placebo comparator | Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. Receives: Drug: MT203 150mg or matching Placebo |
| Cohort 3: MT203 300 mg | Experimental | Six Japanese participants will be randomized to receive a single dose of MT203 300 mg and 2 participants will be randomized to receive matched placebo subcutaneously. Receives: Drug: MT203 300 mg or matching placebo |
| Cohort 3: MT203 300 mg matching placebo | Placebo comparator | Six Japanese participants will be randomized to receive a single dose of MT203 300 mg and 2 participants will be randomized to receive matched placebo subcutaneously. Receives: Drug: MT203 300 mg or matching placebo |
| Cohort 4: MT203 150 mg | Experimental | Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. Receives: Drug: MT203 150mg or matching Placebo |
| Cohort 4: MT203 150 mg matching placebo | Placebo comparator | Six Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously Receives: Drug: MT203 150mg or matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Measured: Baseline up to Day 85
Number of Participants With TEAEs Related to Vital Signs
Measured: Baseline up to Day 85
Number of Participants With TEAEs Related to Body Weight
Measured: Baseline up to Day 85
Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)
Measured: Baseline up to Day 85
Number of Participants With TEAEs Related to Lung Functioning Monitoring
Measured: Baseline up to Day 85
Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis
Measured: Baseline up to Day 85
Secondary outcomes (6)
Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203
Measured: Predose and at multiple time points (up to 84 days) post-dose
Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203
Measured: Predose and at multiple time points (up to 84 days) post-dose
Maximum Observed Serum Concentrations (Cmax) of MT203
Measured: Predose and at multiple time points (up to Day 84) post-dose
Terminal Elimination Half-Life (T1/2) of MT203
Measured: Predose and at multiple time points (up to 84 days) post-dose
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
Measured: Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84
Number of Participants With Positive Response for Anti MT203 Antibody
Measured: Baseline, Hour 168, 336, Day 42, 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354599
- Sponsor's protocol ID
- MT203/CPH-001
- Other IDs
- U1111-1163-4003, JapicCTI-142699
- Status last verified
- May 2016
- First submitted
- 7 Nov 2014
- Last updated
- 20 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tanaka S, Harada S, Hiramatsu N, Nakaya R, Kawamura M. Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men . Int J Clin Pharmacol Ther. 2018 Nov;56(11):507-517. doi: 10.5414/CP203235.
PubMed 30168415
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-center, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate Safety and Pharmacokinetics of Single Subcutaneous Injection of MT203 in Healthy Adult Japanese and Caucasian Male Participants
- ClinicalTrials.gov ID
- NCT02354599
- Acronym / sponsor ID
- MT203/CPH-001
- Conditions
- Healthy Volunteers
- Keywords
- Randomized, double-blind, placebo-controlled, single-dose subcutaneous administration study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 20 Jun 2016
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 evaluate safety, pharmacokinetics and pharmacodynamics of single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male participants.
Detailed description
The drug being tested in this study is called MT203 (Namilumab), which is a human immunoglobulin G1 (IgG1) mAb potently and specifically neutralizing human and macaque granulocyte macrophage colony stimulating factor (GM-CSF). This study will consist of Cohorts 1 to 3 for healthy Japanese participants and Cohort 4 for healthy Caucasian participants. Each cohort will be comprised of 8 participants, of whom 6 participants will be randomized to receive MT203 and 2 participants will be randomized to receive matched placebo.
The study population for the study will consist of 24 Japanese and 8 Caucasian healthy participants. Participants will be assigned to 4 cohorts which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need)::
Cohort 1:- MT203 80 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 2:- MT203 150 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 3:- MT203 300 mg (6 healthy Japanese participants); Matching Placebo (2 healthy Japanese participants) Cohort 4:- MT203 150 mg (6 healthy Caucasian participants); Matching Placebo (2 healthy Caucasian participants).
Dosing of the Caucasian participants (Cohort 4) may occur in parallel with dosing in Japanese participants (Cohorts 1 to 3). Dose escalation will occur in Japanese Cohorts, independent from Cohort 4. The dose escalation will only occur following a review of the blinded safety/tolerability data up to Day 15 from the previous cohort. All participants will receive a single dose on Day 1, admitted from Day -1 to Day 15. Participants will return to the study unit for the pharmacokinetic, pharmacodynamic and safety assessment on Days 22, 29, 43, 57, 71 and 85.
This trial will be conducted in Japan.Overall time to participate in this trial is 85 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: MT203 80 mg | Experimental | Drug: MT203 80 mg or matching PlaceboSix Japanese participants will be randomized to receive a single dose of MT203 80 mg and 2 participants will be randomized to receive matched placebo subcutaneously. |
| Cohort 1: MT203 80 mg matching placebo | Placebo comparator | Drug: MT203 80 mg or matching PlaceboSix Japanese participants will be randomized to receive a single dose of MT203 80 mg and 2 participants will be randomized to receive matched placebo subcutaneously. |
| Cohort 2: MT203 150 mg | Experimental | Drug: MT203 150mg or matching PlaceboSix Japanese participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. |
| Cohort 2: MT203 150 mg matching placebo | Placebo comparator | Drug: MT203 150mg or matching PlaceboSix Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. |
| Cohort 3: MT203 300 mg | Experimental | Drug: MT203 300 mg or matching placeboSix Japanese participants will be randomized to receive a single dose of MT203 300 mg and 2 participants will be randomized to receive matched placebo subcutaneously. |
| Cohort 3: MT203 300 mg matching placebo | Placebo comparator | Drug: MT203 300 mg or matching placeboSix Japanese participants will be randomized to receive a single dose of MT203 300 mg and 2 participants will be randomized to receive matched placebo subcutaneously. |
| Cohort 4: MT203 150 mg | Experimental | Drug: MT203 150mg or matching PlaceboSix Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously. |
| Cohort 4: MT203 150 mg matching placebo | Placebo comparator | Drug: MT203 150mg or matching PlaceboSix Caucasian participants will be randomized to receive a single dose of MT203 150 mg and 2 participants will be randomized to receive matched placebo subcutaneously |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form and any required privacy authorizations prior to the initiation of any study procedures.
- The participant is a healthy adult male of Japanese or Caucasian (born to Caucasian parents and grandparents).
- The participant is aged 20 to 45 years, inclusive, at the time of informed consent.
- The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m2) (for Japanese) or between 18.5 and 30.0 kg/m2 (for Caucasian), inclusive at screening and Day-1.
Key exclusion criteria (21 listed)
- The participant has received any investigational compound within 16 weeks (112 days) prior to the first dose of study medication.
- The participant has received MT203 or other anti-granulocyte-macrophage colony stimulating factor (GM-CSF) drugs in a previous clinical study.
- The participant has been vaccinated within 4 weeks (28 days) prior to the first dose of study medication or is scheduled to be vaccinated during the study.
- The participant is an immediate family member, study site employee or may consent under duress.
- The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease or other abnormalities, which may impact the ability of the participant to participate or potentially confound the study results.
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 |
|---|---|---|
| MT203 80 mg or matching PlaceboAlso: Namilumab, PlaceboMT203 80 mg or matching placebo injection | Drug | Cohort 1: MT203 80 mg, Cohort 1: MT203 80 mg matching placebo |
| MT203 150mg or matching PlaceboAlso: Namilumab, PlaceboMT203 150mg or matching placebo injection | Drug | Cohort 2: MT203 150 mg, Cohort 2: MT203 150 mg matching placebo, Cohort 4: MT203 150 mg, Cohort 4: MT203 150 mg matching placebo |
| MT203 300 mg or matching placeboAlso: Namilumab, PlaceboMT203 300 mg or matching placebo injection | Drug | Cohort 3: MT203 300 mg, Cohort 3: MT203 300 mg matching placebo |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to Vital Signs
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to Body Weight
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to Lung Functioning Monitoring
Time frame: Baseline up to Day 85
Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis
Time frame: Baseline up to Day 85
6 secondary outcomes
Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203
Time frame: Predose and at multiple time points (up to 84 days) post-dose
Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203
Time frame: Predose and at multiple time points (up to 84 days) post-dose
Maximum Observed Serum Concentrations (Cmax) of MT203
Time frame: Predose and at multiple time points (up to Day 84) post-dose
Terminal Elimination Half-Life (T1/2) of MT203
Time frame: Predose and at multiple time points (up to 84 days) post-dose
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
Time frame: Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84
Number of Participants With Positive Response for Anti MT203 Antibody
Time frame: Baseline, Hour 168, 336, Day 42, 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30168415Tanaka S, Harada S, Hiramatsu N, Nakaya R, Kawamura M. Randomized, double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of namilumab in healthy Japanese and Caucasian men . Int J Clin Pharmacol Ther. 2018 Nov;56(11):507-517. doi: 10.5414/CP203235.
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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.
Senior Director study director
Takeda
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 of Healthy Volunteers, run by Takeda at 1 site in Japan.
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 6 inclusion and 21 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 20 Jun 2016. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) (time frame: Baseline up to Day 85). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02354599, which also lists 1 linked publication.
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 20 Jun 2016.