Healthy SubjectsPhase 1NCT02125435
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
A Phase 1 study testing ASP2408 in people with Healthy Subjects and Pharmacokinetics of ASP2408, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, 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
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject weighs at least 50 kg, and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- Results of subject's 12-lead electrocardiogram (ECG) are normal or, if abnormal, the abnormality is not clinically significant as determined by the investigator.
- Female subject must be at least two years postmenopausal OR surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating.
- Male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer.
- Subject is highly likely to comply with the protocol and complete the study.
Who cannot join
- Subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding adequately treated non-melanoma skin cancer.
- Subject has a history of severe allergic or anaphylactic reactions.
- Subject is a female of child-bearing potential.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
- Subject has a positive test for alcohol or drugs of abuse.
- Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in.
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- Subject has a past history of opportunistic infection.
- Subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or mean pulse rate higher than 100 beats per min (bpm).
- Subject is known positive for human immunodeficiency virus (HIV) antibody.
- Subject has a positive TB skin test or Quantiferon Gold test or T-SPOT® test at Screening.
- Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody.
- Subject's laboratory test results:
- alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), are greater than 1.5 times the upper limit of normal
- are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests.
- Subject received any vaccine within 60 days prior to study drug administration.
- Subject received any systemic immunosuppressant agent within 2 months prior to study drug administration.
- Subject has previously received any antibody or therapeutic biologic product prior to study drug administration.
- Subject received any systemic steroid within 2 months or steroid inhaler within 1 month prior to study drug administration.
- Subject has had treatment with prescription, non-prescription or complementary and alternative medicines (CAM) within 14 days prior to study drug administration.
- Subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration.
- Subject is participating in another clinical trial or has participated in another dose group of the current trial.
- Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
- Subject has a history of heavy smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.
Read the detailed description
This is single-dose escalation study composed of 8 sequential cohorts of healthy subjects receiving increasing doses of intravenously administered ASP2408 or matching placebo. Subjects will be confined in the clinic for 8 days.
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP2408
- Being tested
- ASP2408, Placebo
- Keywords
- Healthy subjects, ASP2408, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2408Drug
intravenous
PlaceboDrug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| ASP2408 dose escalation cohort | Experimental | Not described Receives: Drug: ASP2408 |
| Placebo dose escalation cohort | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of ASP2408:AUClast
Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast)
Measured: Days 1-8, 15, 22, 29, 43, 60, 90
Pharmacokinetic parameter of ASP2408: AUCinf
Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Measured: Days 1 -8, 15, 22, 29, 43, 60, 90
Pharmacokinetic parameter of ASP2408:Cmax
Maximum concentration (Cmax)
Measured: Days 1-8, 15, 22, 29, 43, 60, 90
Safety assessed by adverse events, laboratory tests, immunoglobulin, 12-lead electrocardiograms (ECGs), vital signs and anti-2408 antibody formulation
Measured: up to 90 days
Secondary outcomes (4)
Composite of pharmacokinetics of ASP2408: tmax, t1/2, Vz, CLtot
Time to attain Cmax (tmax), apparent terminal elimination half-life (t1/2), Terminal phase volume (Vz), Total Body Clearance (CLtot)
Measured: Days 1-8, 15, 22, 29, 43, 60, 90
Pharmacodynamic parameters of ASP2408: CD80 and CD86 receptor occupancy
Measured: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
Total lymphocyte count
Measured: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
Peripheral lymphocyte subset quantification
Measured: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125435
- Sponsor's protocol ID
- 2408-CL-0101
- Status last verified
- Apr 2014
- First submitted
- 25 Apr 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02125435
- Acronym / sponsor ID
- 2408-CL-0101
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP2408
- Keywords
- Healthy subjects, ASP2408, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Apr 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 objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.
Detailed description
This is single-dose escalation study composed of 8 sequential cohorts of healthy subjects receiving increasing doses of intravenously administered ASP2408 or matching placebo. Subjects will be confined in the clinic for 8 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP2408 dose escalation cohort | Experimental | Drug: ASP2408 |
| Placebo dose escalation cohort | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject weighs at least 50 kg, and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- Results of subject's 12-lead electrocardiogram (ECG) are normal or, if abnormal, the abnormality is not clinically significant as determined by the investigator.
- Female subject must be at least two years postmenopausal OR surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating.
- Male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer.
- Subject is highly likely to comply with the protocol and complete the study.
Key exclusion criteria (23 listed)
- Subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding adequately treated non-melanoma skin cancer.
- Subject has a history of severe allergic or anaphylactic reactions.
- Subject is a female of child-bearing potential.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
- Subject has a positive test for alcohol or drugs of abuse.
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 |
|---|---|---|
| ASP2408intravenous | Drug | ASP2408 dose escalation cohort |
| Placebointravenous | Drug | Placebo dose escalation cohort |
Primary outcome
Pharmacokinetic parameter of ASP2408:AUClast
Time frame: Days 1-8, 15, 22, 29, 43, 60, 90
Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast)
Pharmacokinetic parameter of ASP2408: AUCinf
Time frame: Days 1 -8, 15, 22, 29, 43, 60, 90
Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Pharmacokinetic parameter of ASP2408:Cmax
Time frame: Days 1-8, 15, 22, 29, 43, 60, 90
Maximum concentration (Cmax)
Safety assessed by adverse events, laboratory tests, immunoglobulin, 12-lead electrocardiograms (ECGs), vital signs and anti-2408 antibody formulation
Time frame: up to 90 days
4 secondary outcomes
Composite of pharmacokinetics of ASP2408: tmax, t1/2, Vz, CLtot
Time frame: Days 1-8, 15, 22, 29, 43, 60, 90
Pharmacodynamic parameters of ASP2408: CD80 and CD86 receptor occupancy
Time frame: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
Total lymphocyte count
Time frame: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
Peripheral lymphocyte subset quantification
Time frame: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 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 29 Apr 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 Global Development, 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 Subjects and Pharmacokinetics of ASP2408, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
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 23 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 29 Apr 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 United States. 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?
Pharmacokinetic parameter of ASP2408:AUClast (time frame: Days 1-8, 15, 22, 29, 43, 60, 90). The study lists 4 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 29 Apr 2014.