HealthyPhase 1NCT02140125
A Study to Evaluate the Safety of ASP2408 After Subcutaneous Administration to Healthy Male Subjects
A Phase 1 study testing ASP2408 in people with Healthy and Pharmacokinetics of ASP2408, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Pharmacokinetics of ASP2408
- What is being tested?
- ASP2408
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2012to Oct 2013
- 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 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI (at screening): ≥ 17.6 kg/m2, < 26.4 kg/m2
- Healthy, as judged by the investigator or subinvestigator based on the results of medical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospitalization (Day -2) to immediately before study drug administration
- Subjects who agree to use effective contraception until 90 days after study drug administration
Who cannot join
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study or is scheduled to receive any investigational drugs
- Donated 400 mL of whole blood within 90 days before the study or during the period from the screening, 200 mL of whole blood within 30 days, or blood components within 14 days before the study, or is scheduled to donate 400 mL of whole blood or blood components
- Received medication within 7 days before hospitalization (Day -2) or is scheduled to receive medication
- Received systemic medications influencing immune functions (e.g., steroids, tacrolimus hydrate, anticancer drugs, and biological products) within 365 days before study drug administration
- Received a live virus vaccine (e.g., BCG, polio, measles, and rubella) within 180 days before study drug administration, or cannot agree not to receive these vaccines for 180 days after study drug administration
- Received a live virus vaccine (e.g., BCG, polio, measles, and rubella) within 180 days before study drug administration, or cannot agree not to receive these vaccines for 180 days after study drug administration
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- A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead ECG (see Table 3.3-1) at screening or the day before study drug administration (Day -1)
- Any deviation of the normal ranges in laboratory tests before study drug administration
- Failure to meet any criteria for standard 12-lead ECG for QT assessment at screening
- A positive result for tuberculosis test
- Concurrent or history of drug allergies, anaphylaxis, or severe allergic reaction
- Upper GI disease
- Concurrent or previous hepatic disease (e.g., viral hepatitis and drug-induced liver injury)
- Concurrent or previous heart disease (e.g., congestive heart failure, angina pectoris, and arrhythmia requiring treatment)
- Concurrent or previous respiratory disease (e.g., bronchial asthma and chronic bronchitis; except for a history of childhood asthma)
- Previous operation of gut excision
- Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis; except for a history of calculus)
- Concurrent or previous endocrine disease (e.g., hyperthyroid, abnormality of growth hormone)
- Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)
- Concurrent or previous malignant tumor
- Concurrent or previous serious infection (e.g., sepsis, pneumonia requiring hospitalization, and pyelonephritis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of ASP2408 -Subcutaneous Single-dose, Placebo-controlled Study in Non-elderly Healthy Adult Male Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated.
Read the detailed description
This clinical study will be conducted as a double-blind, placebo-controlled, single ascending subcutaneous dose study. As shown in the table below, the study will be conducted using 3 cohorts, to which a total of 24 subjects will be randomly assigned (18 subjects receiving ASP2408 and 6 subjects receiving placebo). Each cohort will consist of 8 subjects, who will be randomly assigned to either the ASP2408 group or the placebo group at the ratio of 3 to 1.
Each subject will need to be hospitalized until Day 8 (start date of study drug administration will be regarded as Day 1) and will be observed until Day 90. The investigator or subinvestigator will carefully observe each subject for any sign or symptom of adverse events.
- Conditions
- Healthy, Pharmacokinetics of ASP2408
- Being tested
- ASP2408, Placebo
- Keywords
- ASP2408
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2408Drug
subcutaneous administration
PlaceboDrug
subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| ASP2408 low dose group | Experimental | Not described Receives: Drug: ASP2408 |
| ASP2408 middle dose group | Experimental | Not described Receives: Drug: ASP2408 |
| ASP2408 high dose group | Experimental | Not described Receives: Drug: ASP2408 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the incidence of adverse events, vital signs, lab tests, and 12-lead ECG
Measured: Up to 90 days after administration
Secondary outcomes (4)
Pharmacokinetics of serum ASP2408
The pharmacokinetic analysis employed non-compartmental methods using serum concentrations of ASP2408. The following pharmacokinetic parameters were estimated: AUCinf, AUClast, Cmax, CL/F, tmax, t1/2, and Vz/F.
Measured: On day-1, day-2, day-3, day-4, day-5, day-6, day-7, day-8, day-9, day-11, day-13, day-15, day-22, day-29 day-43, day-60 and day-90
CD80/CD86 receptor occupancy
Measured: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
Total lymphocyte count
Measured: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
Peripheral blood lymphocyte subset
Measured: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startAug 2012
- Primary completionOct 2013
- Study completionOct 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140125
- Sponsor's protocol ID
- 2408-CL-9101
- Status last verified
- Jun 2014
- First submitted
- 14 May 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of ASP2408 -Subcutaneous Single-dose, Placebo-controlled Study in Non-elderly Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02140125
- Acronym / sponsor ID
- 2408-CL-9101
- Conditions
- Healthy, Pharmacokinetics of ASP2408
- Keywords
- ASP2408
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 May 2014 (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 purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated.
Detailed description
This clinical study will be conducted as a double-blind, placebo-controlled, single ascending subcutaneous dose study. As shown in the table below, the study will be conducted using 3 cohorts, to which a total of 24 subjects will be randomly assigned (18 subjects receiving ASP2408 and 6 subjects receiving placebo). Each cohort will consist of 8 subjects, who will be randomly assigned to either the ASP2408 group or the placebo group at the ratio of 3 to 1.
Each subject will need to be hospitalized until Day 8 (start date of study drug administration will be regarded as Day 1) and will be observed until Day 90. The investigator or subinvestigator will carefully observe each subject for any sign or symptom of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASP2408 low dose group | Experimental | Drug: ASP2408 |
| ASP2408 middle dose group | Experimental | Drug: ASP2408 |
| ASP2408 high dose group | Experimental | Drug: ASP2408 |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI (at screening): ≥ 17.6 kg/m2, < 26.4 kg/m2
- Healthy, as judged by the investigator or subinvestigator based on the results of medical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospitalization (Day -2) to immediately before study drug administration
- Subjects who agree to use effective contraception until 90 days after study drug administration
Key exclusion criteria (21 listed)
- Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study or is scheduled to receive any investigational drugs
- Donated 400 mL of whole blood within 90 days before the study or during the period from the screening, 200 mL of whole blood within 30 days, or blood components within 14 days before the study, or is scheduled to donate 400 mL of whole blood or blood components
- Received medication within 7 days before hospitalization (Day -2) or is scheduled to receive medication
- Received systemic medications influencing immune functions (e.g., steroids, tacrolimus hydrate, anticancer drugs, and biological products) within 365 days before study drug administration
- Received a live virus vaccine (e.g., BCG, polio, measles, and rubella) within 180 days before study drug administration, or cannot agree not to receive these vaccines for 180 days after study drug administration
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 |
|---|---|---|
| ASP2408subcutaneous administration | Drug | ASP2408 high dose group, ASP2408 low dose group, ASP2408 middle dose group |
| Placebosubcutaneous administration | Drug | Placebo group |
Primary outcome
Safety assessed by the incidence of adverse events, vital signs, lab tests, and 12-lead ECG
Time frame: Up to 90 days after administration
4 secondary outcomes
Pharmacokinetics of serum ASP2408
Time frame: On day-1, day-2, day-3, day-4, day-5, day-6, day-7, day-8, day-9, day-11, day-13, day-15, day-22, day-29 day-43, day-60 and day-90
CD80/CD86 receptor occupancy
Time frame: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
Total lymphocyte count
Time frame: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
Peripheral blood lymphocyte subset
Time frame: On day-1, day-2, day-3, day-5, day-8, day 15, day-22, day-29 and day-90
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 1 Jul 2014.
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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 director
Astellas Pharma Inc
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 ASP2408 in people with Healthy and Pharmacokinetics of ASP2408, run by Astellas Pharma Inc 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 3 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 1 Jul 2014. 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?
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 assessed by the incidence of adverse events, vital signs, lab tests, and 12-lead ECG (time frame: Up to 90 days after administration). 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 1 Jul 2014.