Pharmacokinetics of ASP2408Phase 1NCT02150070
A Study to Evaluate a Single Intravenous (IV) Dose Using a New Manufactured Clone and Single Ascending Doses of Subcutaneous (SC) Injections
A Phase 1 study testing ASP2408 in people with Pharmacokinetics of ASP2408 and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production clone and also following single ascending doses of subcutaneous (SC) injections of the same clinical trial material. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of ASP2408, Healthy Subjects
- 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 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
- The subject weighs at least 50 kg, a maximum of 92.5 kg and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- The subject's 12-lead electrocardiogram (ECG) results are normal
- The female subject must be at least two years postmenopausal OR surgically sterile and not pregnant or lactating
- The male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer
Who cannot join
- The 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
- The subject has a history of severe allergic or anaphylactic reactions
- The subject is a female of childbearing potential
- The 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 the past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
- The subject has a positive test for alcohol or drugs of abuse
- The 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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- The subject has a past history of opportunistic infection
- The 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 minute (bpm)
- The subject is known positive for human immunodeficiency virus (HIV) antibody
- The subject has a positive tuberculosis (TB) skin test, Quantiferon Gold test or T-SPOT® test
- The 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 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values are greater than 1.5 times the upper limit of normal
- Subject's laboratory test results are outside the normal limits and considered to be clinically significant
- The subject received any vaccine within 60 days prior to study drug administration
- The subject received any systemic immunosuppressant agent within 2 months prior to study drug administration
- The subject has previously received any antibody or therapeutic biologic product prior to study drug administration
- The subject received any systemic steroid within 2 months or steroid inhaler within 1 month prior to study drug administration
- The subject has had treatment with prescription, non-prescription or complementary and alternative medicines (CAM) within 14 days prior to study drug administration with the exception of stable hormone replacement therapy (HRT) and/or intermittent acetaminophen (to a maximum of 2 g/day)
- The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
- The subject is participating in another clinical trial or has participated in another dose group of the current trial
- The 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
- The subject has any other condition which precludes the subject's participation in the trial
- The 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 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Intravenous Administration of ASP2408 Manufactured From a New Production Clone and Following Single Ascending Doses of Subcutaneous Injections in Healthy Subjects
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production clone and also following single ascending doses of subcutaneous (SC) injections of the same clinical trial material.
Read the detailed description
The four doses will be studied in sequential cohorts of 8 subjects each, starting with the IV dose, followed by the subcutaneous doses in ascending order of dose. Within each cohort, subjects will be randomized to either active drug or matching placebo in a 3:1 ratio (6 active and 2 placebo).
All subjects in each arm will be confined for 8 days and followed for a minimum of 90 days up to 9 months if necessary. Subjects who have study drug terminated should remain in the study, if possible and have scheduled procedures and follow-up.
Subjects who have detectable blood levels of ASP2408 after Day 90 will be unblinded and followed monthly until ASP2408 levels are below the limit of quantification. In addition, subjects who have persistent anti-ASP2408 antibodies after Day 90 will be unblinded and followed every 30 (± 3) days for up to 9 months until the level of these antibodies are declining, no longer detectable, and/or have no clinical consequence.
- Conditions
- Pharmacokinetics of ASP2408, Healthy Subjects
- Being tested
- ASP2408, Placebo
- Keywords
- Healthy subjects, ASP2408, Rheumatoid arthritis, Safety and Tolerability, Pharmacokinetics
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2408Drug
Intravenous (IV) infusion and subcutaneous (SC) injection
PlaceboDrug
Intravenous (IV) infusion and Subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Intravenous ASP2408 | Experimental | Not described Receives: Drug: ASP2408 |
| Subcutaneous ASP2408 low dose | Experimental | Not described Receives: Drug: ASP2408 |
| Subcutaneous ASP2408 middle dose | Experimental | Not described Receives: Drug: ASP2408 |
| Subcutaneous ASP2408 high dose | Experimental | Not described Receives: Drug: ASP2408 |
| Intravenous Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Subcutaneous Placebo | 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 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Pharmacokinetic parameter of ASP2408: AUCinf
Area under the concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Measured: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Pharmacokinetic parameter of ASP2408: Cmax
Maximum concentration (Cmax)
Measured: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Safety assessed by adverse events (AEs), laboratory tests, immunoglobulin quantification (class), 12-lead electrocardiograms, vital signs and anti-ASP2408 antibody formation
Measured: Up to day 90
Secondary outcomes (2)
Composite of pharmacokinetics of ASP2408: tmax, t 1/2, Vz/F, CL/F and F (%)
Time to attain Cmax (tmax), apparent terminal elimination half-life (t 1/2), apparent volume of distribution (Vz/F), apparent body clearance (CL/F) and absolute bioavailability (F%)
Measured: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Pharmacodynamic Profile: CD80 and CD86 receptor occupancy, peripheral lymphocyte subset quantification (leukocyte phenotypes) and total lymphocyte count
Measured: Days 1-3, 5, 8, 15, 22, 29, 43, 60 and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of ASP2408Studies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150070
- Sponsor's protocol ID
- 2408-CL-0102
- Status last verified
- May 2014
- First submitted
- 27 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Intravenous Administration of ASP2408 Manufactured From a New Production Clone and Following Single Ascending Doses of Subcutaneous Injections in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02150070
- Acronym / sponsor ID
- 2408-CL-0102
- Conditions
- Pharmacokinetics of ASP2408, Healthy Subjects
- Keywords
- Healthy subjects, ASP2408, Rheumatoid arthritis, Safety and Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 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 determine the safety, tolerability, and pharmacokinetics (PK) after intravenous (IV) administration of ASP2408 manufactured from a new production clone and also following single ascending doses of subcutaneous (SC) injections of the same clinical trial material.
Detailed description
The four doses will be studied in sequential cohorts of 8 subjects each, starting with the IV dose, followed by the subcutaneous doses in ascending order of dose. Within each cohort, subjects will be randomized to either active drug or matching placebo in a 3:1 ratio (6 active and 2 placebo).
All subjects in each arm will be confined for 8 days and followed for a minimum of 90 days up to 9 months if necessary. Subjects who have study drug terminated should remain in the study, if possible and have scheduled procedures and follow-up.
Subjects who have detectable blood levels of ASP2408 after Day 90 will be unblinded and followed monthly until ASP2408 levels are below the limit of quantification. In addition, subjects who have persistent anti-ASP2408 antibodies after Day 90 will be unblinded and followed every 30 (± 3) days for up to 9 months until the level of these antibodies are declining, no longer detectable, and/or have no clinical consequence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Intravenous ASP2408 | Experimental | Drug: ASP2408 |
| Subcutaneous ASP2408 low dose | Experimental | Drug: ASP2408 |
| Subcutaneous ASP2408 middle dose | Experimental | Drug: ASP2408 |
| Subcutaneous ASP2408 high dose | Experimental | Drug: ASP2408 |
| Intravenous Placebo | Placebo comparator | Drug: Placebo |
| Subcutaneous Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject weighs at least 50 kg, a maximum of 92.5 kg and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- The subject's 12-lead electrocardiogram (ECG) results are normal
- The female subject must be at least two years postmenopausal OR surgically sterile and not pregnant or lactating
- The male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer
Key exclusion criteria (23 listed)
- The 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
- The subject has a history of severe allergic or anaphylactic reactions
- The subject is a female of childbearing potential
- The 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 the past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
- The 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 (IV) infusion and subcutaneous (SC) injection | Drug | Intravenous ASP2408, Subcutaneous ASP2408 high dose, Subcutaneous ASP2408 low dose, Subcutaneous ASP2408 middle dose |
| PlaceboIntravenous (IV) infusion and Subcutaneous (SC) injection | Drug | Intravenous Placebo, Subcutaneous Placebo |
Primary outcome
Pharmacokinetic parameter of ASP2408: AUClast
Time frame: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 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 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Area under the concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
Pharmacokinetic parameter of ASP2408: Cmax
Time frame: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Maximum concentration (Cmax)
Safety assessed by adverse events (AEs), laboratory tests, immunoglobulin quantification (class), 12-lead electrocardiograms, vital signs and anti-ASP2408 antibody formation
Time frame: Up to day 90
2 secondary outcomes
Composite of pharmacokinetics of ASP2408: tmax, t 1/2, Vz/F, CL/F and F (%)
Time frame: Days 1-9, 11, 13, 15, 22, 29, 43, 60, and 90
Pharmacodynamic Profile: CD80 and CD86 receptor occupancy, peripheral lymphocyte subset quantification (leukocyte phenotypes) and total lymphocyte count
Time frame: Days 1-3, 5, 8, 15, 22, 29, 43, 60 and 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 May 2014.
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 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 Pharmacokinetics of ASP2408 and Healthy Subjects, 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 4 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 May 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 1-9, 11, 13, 15, 22, 29, 43, 60, and 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 May 2014.