Healthy Japanese and Caucasian Male AdultsPhase 1NCT02426021
Phase 1 Single Subcutaneous Dose Study of MLN1202
A Phase 1 study testing MLN1202 in people with Healthy Japanese and Caucasian Male Adults, run by Takeda at 1 site in Japan.
Trial summary
The objective of the study is to investigate the safety, pharmacokinetics, and pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults. 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 Japanese and Caucasian Male Adults
- What is being tested?
- MLN1202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2015to Nov 2015
- 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 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 (ICF) prior to the initiation of any study procedures.
- The participant is a healthy adult man who is defined as Japanese (all parents and grandparents of the participant are Japanese) or Caucasian (all parents and grandparents of the participant are Caucasian).
- The participant is between 20 and 45 years of age at the time of informed consent.
- The participant has a body weight of at least 50 kg and has a body mass index (BMI) between 18.5 and 25.0 kg /m2 when the participant is Japanese or between 18.5 and 30.0 kg /m2 when the participant is Caucasian at the time of screening and baseline examination.
- A male participant who is sexually active with a female partner of childbearing potential and who has not received contraceptive therapy agrees to use adequate contraception from the time of informed consent until 12 weeks (84 days) after administration of the study drug.
Who cannot join
- The participant has received any other investigational compound within 16 weeks (112 days) prior to administration of the study drug.
- The participant has previously received agents containing MLN1202, a monoclonal antibody or monoclonal antibody fragment.
- The participant has been vaccinated within 4 weeks (28 days) prior to administration of the study drug or is planning to be vaccinated during the study period.
- The participant is a study site employee or immediate family member of the employee, or may consent under duress.
- The participant has poorly-controlled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease, hemorrhagic disorder or other abnormalities which may impact the ability of the participant to participate or potentially confound the study results.
- The participant has recurrent serious or poorly-controlled infection and is considered to have difficulty participating in the study by the investigator.
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- The participant has a history of hypersensitivity or allergies to MLN1202 or additives contained in MLN1202 preparations.
- The participant has a history of hypersensitivity or allergies to monoclonal antibodies other than MLN1202.
- The participant has positive results in urine drug tests at screening.
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol dependence within 2 years prior to the study visit at screening or is unwilling to agree to abstain from alcohol and drugs throughout the study period.
- The participant requires any excluded medication or food products listed in the Excluded Medications and Dietary Products (see section 7.3) during the study period.
- The participant intends to donate sperm during the study period or period until 12 weeks (84 days) after administration of the study drug.
- The participant has a history of cancer.
- The participant has, is suspected of having, or has a history of active tuberculosis or latent tuberculosis infection.
- The participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis B virus antibody (hepatitis B surface antibody [HBsAb]/ hepatitis B core antibody [HBcAb]), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at screening. This does not include the participant who has a positive test result only for HBsAb due to HBV vaccination.
- The participant has used nicotine-containing products (cigarettes, pipes, cigars, chewing tobacco, nicotine patches, or nicotine gum, etc.) within 4 weeks (28 days) prior to administration of the study drug.
- The participant has poor peripheral venous access.
- The participant has undergone whole blood collection of at least 200 mL within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to administration of the study drug.
- The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to administration of the study drug.
- The participant has undergone blood component collection within 2 weeks (14 days) prior to administration of the study drug.
- The participant has any clinically significant electrocardiographic (ECG) abnormalities at the time of screening or baseline examination.
- The participant has abnormal laboratory values that suggest a clinically significant underlying disease, or the participant has the following lab abnormalities at the time of screening or baseline examination: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 × the upper limits of normal, or differential white blood count (monocytes) < the lower limit of normal.
- The following criteria will be evaluated by laboratory tests at the screening: insulin (fasting), parathyroid hormone (PTH) (intact).
- The participant has systolic blood pressure <80 mmHg or diastolic blood pressure <45 mmHg, or systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg at the time of screening, baseline examination or examination prior to administration of the study drug.
- The participant is receiving treatment for a wound and is, in the opinion of the investigator, unsuitable to participate in the study.
- The participant is scheduled to undergo surgery within 12 weeks (84 days) after administration of the study drug.
- In the opinion of the investigator, the participant is unlikely to comply with the protocol or is unsuitable for any other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injection of MLN1202 in the Japanese and Caucasian Healthy Male Participants
The objective of the study is to investigate the safety, pharmacokinetics, and pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults.
Read the detailed description
This is a single dose, phase 1 study in healthy Japanese and Caucasian male adults.
Japanese subjects will be assigned to Cohort J1 (at a dose of 75 mg), Cohort J2 (105 mg), Cohort J3 (150 mg), or Cohort J4 (450 mg) in a randomized, double-blind, placebo-controlled manner, while Caucasian subjects to Cohort C1 (at a dose of 75 mg) or Cohort C2 (150 mg) in an open-label manner.
Takeda has made a business decision to terminate this study due to portfolio re-prioritization. There were no safety or efficacy concerns.
- Being tested
- MLN1202, MLN1202 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN1202Drug
Subcutaneous administration of MLN1202
MLN1202 PlaceboDrug
Subcutaneous administration of MLN1202 placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort J1: MLN1202 (75 mg) | Experimental | Single subcutaneous administration of MLN1202 (75 mg) in 6 healthy Japanese male adults Receives: Drug: MLN1202 |
| Cohort J1: placebo | Experimental | Single subcutaneous administration of placebo in 2 healthy Japanese male adults Receives: Drug: MLN1202 Placebo |
| Cohort J2:MLN1202 (105 mg) | Experimental | Single subcutaneous administration of MLN1202 (105 mg) in 6 healthy Japanese male adults Receives: Drug: MLN1202 |
| Cohort J2: placebo | Experimental | Single subcutaneous administration of placebo in 2 healthy Japanese male adults Receives: Drug: MLN1202 Placebo |
| Cohort J3: MLN1202 (150 mg) | Experimental | Single subcutaneous administration of MLN1202 (150 mg) in 6 healthy Japanese male adults Receives: Drug: MLN1202 |
| Cohort J3: placebo | Experimental | Single subcutaneous administration of placebo in 2 healthy Japanese male adults Receives: Drug: MLN1202 Placebo |
| Cohort J4: MLN1202 (450 mg) | Experimental | Single subcutaneous administration of MLN1202 (450 mg) in 6 healthy Japanese male adults Receives: Drug: MLN1202 |
| Cohort J4: placebo | Experimental | Single subcutaneous administration of placebo in 2 healthy Japanese male adults Receives: Drug: MLN1202 Placebo |
| Cohort C1: MLN1202 (75 mg) | Experimental | Single subcutaneous administration of MLN1202 (75 mg) in healthy Causacian male adults Receives: Drug: MLN1202 |
| Cohort C2: MLN1202 (150 mg) | Experimental | Single subcutaneous administration of MLN1202 (150 mg) in healthy Causacian male adults Receives: Drug: MLN1202 |
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
The adverse event is defined as any unfavorable and unintended sign, symptom, or disease that develops when a drug is administered, irrespective of the causal relationship to the drug.
Measured: Up to Day 37
Secondary outcomes (4)
Maximum observed serum concentration (Cmax) of MLN1202
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Up to Day 37
Area under the serum concentration-time curve (AUC) of MLN1202 in serum
Area under the serum concentration-time curve during a dosing interval.
Measured: Up to Day 37
Changes in serum monocyte chemoattractant protein-1 (MCP-1) concentrations
Serum MCP-1 concentrations will be measured at each protocol-specified time point, when blood samples are collected.
Measured: Up to Day 37
Changes in monocyte count from baseline
The absolute monocyte count will be determined at each protocol-specified time point, when blood samples are collected.
Measured: Up to Day 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Business decision; No Safety or Efficacy Concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese and Caucasian Male AdultsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study chair, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426021
- Sponsor's protocol ID
- MLN1202/CPH-001
- Other IDs
- U1111-1169-0038, JapicCTI-152874
- Status last verified
- Oct 2016
- First submitted
- 21 Apr 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injection of MLN1202 in the Japanese and Caucasian Healthy Male Participants
- ClinicalTrials.gov ID
- NCT02426021
- Acronym / sponsor ID
- MLN1202/CPH-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision; No Safety or Efficacy Concerns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Apr 2015 (estimated)
- 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 objective of the study is to investigate the safety, pharmacokinetics, and pharmacodynamic effect of a single dose of MLN1202 in healthy Japanese male adults.
Detailed description
This is a single dose, phase 1 study in healthy Japanese and Caucasian male adults.
Japanese subjects will be assigned to Cohort J1 (at a dose of 75 mg), Cohort J2 (105 mg), Cohort J3 (150 mg), or Cohort J4 (450 mg) in a randomized, double-blind, placebo-controlled manner, while Caucasian subjects to Cohort C1 (at a dose of 75 mg) or Cohort C2 (150 mg) in an open-label manner.
Takeda has made a business decision to terminate this study due to portfolio re-prioritization. There were no safety or efficacy concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort J1: MLN1202 (75 mg) | Experimental | Drug: MLN1202Single subcutaneous administration of MLN1202 (75 mg) in 6 healthy Japanese male adults |
| Cohort J1: placebo | Experimental | Drug: MLN1202 PlaceboSingle subcutaneous administration of placebo in 2 healthy Japanese male adults |
| Cohort J2:MLN1202 (105 mg) | Experimental | Drug: MLN1202Single subcutaneous administration of MLN1202 (105 mg) in 6 healthy Japanese male adults |
| Cohort J2: placebo | Experimental | Drug: MLN1202 PlaceboSingle subcutaneous administration of placebo in 2 healthy Japanese male adults |
| Cohort J3: MLN1202 (150 mg) | Experimental | Drug: MLN1202Single subcutaneous administration of MLN1202 (150 mg) in 6 healthy Japanese male adults |
| Cohort J3: placebo | Experimental | Drug: MLN1202 PlaceboSingle subcutaneous administration of placebo in 2 healthy Japanese male adults |
| Cohort J4: MLN1202 (450 mg) | Experimental | Drug: MLN1202Single subcutaneous administration of MLN1202 (450 mg) in 6 healthy Japanese male adults |
| Cohort J4: placebo | Experimental | Drug: MLN1202 PlaceboSingle subcutaneous administration of placebo in 2 healthy Japanese male adults |
| Cohort C1: MLN1202 (75 mg) | Experimental | Drug: MLN1202Single subcutaneous administration of MLN1202 (75 mg) in healthy Causacian male adults |
| Cohort C2: MLN1202 (150 mg) | Experimental | Drug: MLN1202Single subcutaneous administration of MLN1202 (150 mg) in healthy Causacian male adults |
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 (ICF) prior to the initiation of any study procedures.
- The participant is a healthy adult man who is defined as Japanese (all parents and grandparents of the participant are Japanese) or Caucasian (all parents and grandparents of the participant are Caucasian).
- The participant is between 20 and 45 years of age at the time of informed consent.
- The participant has a body weight of at least 50 kg and has a body mass index (BMI) between 18.5 and 25.0 kg /m2 when the participant is Japanese or between 18.5 and 30.0 kg /m2 when the participant is Caucasian at the time of screening and baseline examination.
Key exclusion criteria (27 listed)
- The participant has received any other investigational compound within 16 weeks (112 days) prior to administration of the study drug.
- The participant has previously received agents containing MLN1202, a monoclonal antibody or monoclonal antibody fragment.
- The participant has been vaccinated within 4 weeks (28 days) prior to administration of the study drug or is planning to be vaccinated during the study period.
- The participant is a study site employee or immediate family member of the employee, or may consent under duress.
- The participant has poorly-controlled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, or endocrine disease, hemorrhagic disorder 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 |
|---|---|---|
| MLN1202Subcutaneous administration of MLN1202 | Drug | Cohort C1: MLN1202 (75 mg), Cohort C2: MLN1202 (150 mg), Cohort J1: MLN1202 (75 mg), Cohort J2:MLN1202 (105 mg), Cohort J3: MLN1202 (150 mg), Cohort J4: MLN1202 (450 mg) |
| MLN1202 PlaceboSubcutaneous administration of MLN1202 placebo | Drug | Cohort J1: placebo, Cohort J2: placebo, Cohort J3: placebo, Cohort J4: placebo |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events
Time frame: Up to Day 37
The adverse event is defined as any unfavorable and unintended sign, symptom, or disease that develops when a drug is administered, irrespective of the causal relationship to the drug.
4 secondary outcomes
Maximum observed serum concentration (Cmax) of MLN1202
Time frame: Up to Day 37
Area under the serum concentration-time curve (AUC) of MLN1202 in serum
Time frame: Up to Day 37
Changes in serum monocyte chemoattractant protein-1 (MCP-1) concentrations
Time frame: Up to Day 37
Changes in monocyte count from baseline
Time frame: Up to Day 37
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
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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.
Medical Director study chair
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 testing MLN1202 in people with Healthy Japanese and Caucasian Male Adults, 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 27 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: withdrawn, as of the sponsor's last update on 27 Oct 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. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: Up to Day 37). 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 27 Oct 2016.