Pharmacokinetics of AlefaceptPhase 1NCT00653822
A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers
A Phase 1 study testing alefacept in people with Pharmacokinetics of Alefacept, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties and safety profile of alefacept in Caucasian and Japanese healthy subjects Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Alefacept
- What is being tested?
- alefacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian or Japanese healthy subject with a body mass index (BMI) of 18 to 29 kg/m2, inclusive
- Japanese subject is first generation, born in Japan from parents of Japanese decent, and has resided outside of Japan for 5 years or less OR Caucasian subject is Hispanic or non-Hispanic, born of parents of European decent (not Mestizo or mixed race)
- Subject must have clinical laboratory test results within the normal therapeutic range or, if abnormal, the results are not clinically significant as determined by the investigator
Who cannot join
- CD4+ lymphocyte count outside normal limits at Screening
- Received vaccine within 60 days prior to study drug administration
- History of drug or alcohol abuse within the 2 years prior to the study drug administration
- Treatment with any systemic immunosuppressant agent within 6 months prior to study drug administration
- Treatment with any antibody or biologic product within 6 months prior to study drug administration
- Treatment with any systemic steroid or steroid inhaler within 2 months prior to study drug administration
- A smoking habit of greater than 10 cigarettes a day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Dose Study to Assess the Tolerability, Safety, and Pharmacokinetics of Alefacept in Caucasian and Japanese Healthy Volunteers
The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties and safety profile of alefacept in Caucasian and Japanese healthy subjects
- Conditions
- Pharmacokinetics of Alefacept
- Being tested
- alefacept, placebo
- Keywords
- Amevive, alefacept, pharmacokinetics, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alefaceptDrug
Also called Amevive, ASP0485
IC and SC
placeboDrug
IV and SC
| Study group | Role | What they receive |
|---|---|---|
| 1a | Experimental | IV Receives: Drug: alefacept |
| 1b | Placebo comparator | IV Receives: Drug: placebo |
| 2a | Experimental | Lower SC dose Receives: Drug: alefacept |
| 2b | Placebo comparator | SC to match lower dose Receives: Drug: placebo |
| 3a | Experimental | Higher SC dose Receives: Drug: alefacept |
| 3b | Placebo comparator | SC to match higher dose Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum alefacept pharmacokinetic parameters
Measured: Days 1-8,15, 22, 29 and 43
Secondary outcomes (2)
Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets
Measured: Days 1-8, 15, 22, 29 and 43
Safety variables including anti-alefacept antibodies
Measured: Days 1-8, 15, 22, 29 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of AlefaceptStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653822
- Sponsor's protocol ID
- 0485-CL-J101
- Status last verified
- Aug 2008
- First submitted
- 2 Apr 2008
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Dose Study to Assess the Tolerability, Safety, and Pharmacokinetics of Alefacept in Caucasian and Japanese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00653822
- Acronym / sponsor ID
- 0485-CL-J101
- Conditions
- Pharmacokinetics of Alefacept
- Keywords
- Amevive, alefacept, pharmacokinetics, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 Apr 2008 (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 compare the pharmacokinetic and pharmacodynamic properties and safety profile of alefacept in Caucasian and Japanese healthy subjects
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1a | Experimental | Drug: alefaceptIV |
| 1b | Placebo comparator | Drug: placeboIV |
| 2a | Experimental | Drug: alefaceptLower SC dose |
| 2b | Placebo comparator | Drug: placeboSC to match lower dose |
| 3a | Experimental | Drug: alefaceptHigher SC dose |
| 3b | Placebo comparator | Drug: placeboSC to match higher dose |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caucasian or Japanese healthy subject with a body mass index (BMI) of 18 to 29 kg/m2, inclusive
- Japanese subject is first generation, born in Japan from parents of Japanese decent, and has resided outside of Japan for 5 years or less OR Caucasian subject is Hispanic or non-Hispanic, born of parents of European decent (not Mestizo or mixed race)
- Subject must have clinical laboratory test results within the normal therapeutic range or, if abnormal, the results are not clinically significant as determined by the investigator
Key exclusion criteria (7 listed)
- CD4+ lymphocyte count outside normal limits at Screening
- Received vaccine within 60 days prior to study drug administration
- History of drug or alcohol abuse within the 2 years prior to the study drug administration
- Treatment with any systemic immunosuppressant agent within 6 months prior to study drug administration
- Treatment with any antibody or biologic product within 6 months prior to 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 |
|---|---|---|
| alefaceptAlso: Amevive, ASP0485IC and SC | Drug | 1a, 2a, 3a |
| placeboIV and SC | Drug | 1b, 2b, 3b |
Primary outcome
Serum alefacept pharmacokinetic parameters
Time frame: Days 1-8,15, 22, 29 and 43
2 secondary outcomes
Pharmacodynamic parameters of total lymphocyte count and peripheral lymphocyte subsets
Time frame: Days 1-8, 15, 22, 29 and 43
Safety variables including anti-alefacept antibodies
Time frame: Days 1-8, 15, 22, 29 and 43
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 28 Feb 2013.
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.
Use Central Contact study director
Astellas Pharma US, 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 alefacept in people with Pharmacokinetics of Alefacept, run by Astellas Pharma 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 3 inclusion and 7 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 28 Feb 2013. 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?
Serum alefacept pharmacokinetic parameters (time frame: Days 1-8,15, 22, 29 and 43). 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 28 Feb 2013; AzTrials last refreshed its copy on 8 Nov 2026.