Healthy VolunteersPhase 1NCT04017208
A Study to Assess ASP2713 in Healthy Subjects
A Phase 1 study testing ASP2713 in people with Healthy Volunteers, run by Astellas Pharma Global Development, Inc..
Trial summary
The purpose of this study is to evaluate safety and tolerability of ASP2713 in healthy participants. The study will also evaluate the pharmacokinetics and pharmacodynamics of ASP2713. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ASP2713
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Aug 2020
- 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 has a body mass index range of 18.5 to 32.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
- Subject has absolute total B cell counts above the lower limit of normal (LLN) reference range measured by flow cytometry at both screening visits 1 and 2. When B cell count reduction (> 50% reduction from the lowest screening baseline value lasting > 6 days postdose in > 4 subjects within a cohort) is observed in a previously enrolled cohort, the subsequent cohorts will enroll only subjects with screening B cell counts above the median of the reference range, as defined by the laboratory.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP)
- WOCBP who agrees to follow the contraceptive guidance starting at screening and for at least 90 days after study drug administration
- Female subject must agree not to breastfeed 90 days prior to screening and throughout the study period and for 90 days after study drug administration.
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- Female subject must not donate ova starting at screening and throughout the study period and for 90 days after study drug administration.
- Male subject with a female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 90 days after study drug administration.
- Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after study drug administration.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner(s) is(are) breastfeeding throughout the study period and for 90 days after study drug administration.
- Subject agrees not to participate in another interventional study while participating in the present study, defined as signing of the informed consent form until completion of the last study visit.
Who cannot join
- Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- Subject has known or suspected hypersensitivity to ASP2713 or any components of the formulation used.
- Subject has had previous exposure with ASP2713.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase and total bilirubin [TBL]) above the upper limit of normal (ULN) at screening visit 1 or on day -2. In such a case, the assessment may be repeated once.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic seasonal allergies) prior to study drug administration.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
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- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
- Subject has any clinically significant abnormality on physical examination, electrocardiogram (ECG) and clinical laboratory tests at screening visit 1 or day -2.
- Subject has a mean pulse < 45 or > 90 bpm; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (measurements taken in triplicate after subject has been resting in the supine position for 5 minutes; pulse will be measured automatically) at screening visit 1 or on day -2. If the mean blood pressure exceeds the limits above, 1 additional triplicate measurement can be taken.
- Subject has a mean corrected QT interval using Fridericia's formula (QTcF) of > 430 msec (for male subjects) and > 450 msec (for female subjects) at screening visit 1 or on day -2. If the mean QTcF exceeds the limits above, 1 additional triplicate electrocardiogram (ECG) can be taken.
- Subject has used any prescribed or nonprescribed drugs (including vitamins, natural and herbal remedies, e.g., St John's Wort) in 2 weeks prior to study drug administration, except for occasional use of acetaminophen (up to 2 g per day), hormonal contraceptives or hormone replacement therapy.
- Subject has smoked or has used tobacco-containing products and nicotine or nicotine-containing products within 6 months prior to screening.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within the past 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor) or the subject tests positive for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -2.
- Subjects has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 3 months prior to day -2.
- Subject has had significant blood loss, donated 1 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 day -1.
- Subject has a positive serology test for hepatitis B surface antigen, hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies, hepatitis B core antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.
- Subject has a positive tuberculosis blood test, Quantiferon Gold® or T-SPOT® test at screening.
- Subject has received any vaccine within 60 days prior to study drug administration.
- Subject has received any systemic immunosuppressant agent within 2 months prior to study drug administration.
- Subject has previously received any antibody or therapeutic biologic product 6 months prior to study drug administration.
- Subject has received any systemic steroid within 2 months prior to study drug administration.
- Subject has participated in any clinical study or has been treated with any investigational drugs within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Subject has an absolute lymphocyte count below LLN at screening.
- Subject has any condition which makes the subject unsuitable for study participation.
About this study
Official title: A Phase 1 Single Ascending Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2713 in Healthy Subjects
The purpose of this study is to evaluate safety and tolerability of ASP2713 in healthy participants. The study will also evaluate the pharmacokinetics and pharmacodynamics of ASP2713.
Read the detailed description
This study will consist of a screening period, a single residential period of 10 days/9 nights and a safety follow up period. Subjects will be randomized to either ASP2713 or placebo.
- Conditions
- Healthy Volunteers
- Being tested
- ASP2713, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2713Drug
Administered intravenously
placeboDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| ASP2713 | Experimental | Participants will receive a single dose of ASP2713. Up to 8 dose levels will be administered in the study. Receives: Drug: ASP2713 |
| Placebo | Placebo comparator | Participants will receive a single dose of placebo. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Measured: Up to 90 days
Number of participants with laboratory value abnormalities and/or adverse events (AEs) [related to treatment]
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 90 days
Number of participants with vital sign abnormalities and /or adverse events (AEs) [related to treatment]
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 90 days
Number of participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant ECG values.
Measured: Up to 90 days
Number of participants who develop anti-drug antibodies (ADA) to ASP2713
Number of participants with presence of ADA will be assessed.
Measured: Up to 90 days
Secondary outcomes (10)
Pharmacokinetics (PK) of ASP2713 in serum: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the pharmacokinetic (PK) serum samples collected.
Measured: Up to 90 days
PK of ASP2713 in serum: AUC from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK serum samples collected.
Measured: Up to 90 days
PK of ASP2713 in serum: AUC extrapolated from time to infinity as a percentage of total area under the concentration-time curve (AUCinf(%extrap))
AUCinf (%extrap) will be recorded from the PK serum samples collected.
Measured: Up to 90 days
PK of ASP2713 in serum: Maximum concentration (Cmax)
Cmax will be recorded from the PK serum samples collected.
Measured: Up to 90 days
PK of ASP2713 in serum: Clearance (CL)
CL will be recorded from PK serum samples collected.
Measured: Up to 90 days
PK of ASP2713 in serum: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
tlag will be recorded from PK serum samples collected.
Measured: Up to 90 days
PK of ASP2713 in serum: Time of the maximum concentration (tmax)
Tmax will be recorded from the PK serum samples collected.
Measured: Up to 90 days
PK of ASP2713 in serum: Terminal elimination half-life (t1/2)
t1/2 will be recorded from PK serum samples collected.
Measured: Up to 90 days
PK of ASP2713 in serum: Apparent volume of distribution during the terminal phase (Vz)
Vz will be recorded from PK serum samples collected.
Measured: Up to 90 days
Pharmacodynamics assessed by ASP2713 receptor occupancy
Blood samples will be collected to measure how much ASP2713 binds to the target on the cell surface.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: A business decision was made to not initiate this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 0 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
- NCT04017208
- Sponsor's protocol ID
- 2713-CL-0101
- Status last verified
- Aug 2019
- First submitted
- 10 Jul 2019
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Ascending Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2713 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04017208
- Acronym / sponsor ID
- 2713-CL-0101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A business decision was made to not initiate this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 12 Jul 2019 (actual)
- 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 evaluate safety and tolerability of ASP2713 in healthy participants. The study will also evaluate the pharmacokinetics and pharmacodynamics of ASP2713.
Detailed description
This study will consist of a screening period, a single residential period of 10 days/9 nights and a safety follow up period. Subjects will be randomized to either ASP2713 or placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP2713 | Experimental | Drug: ASP2713Participants will receive a single dose of ASP2713. Up to 8 dose levels will be administered in the study. |
| Placebo | Placebo comparator | Drug: placeboParticipants will receive a single dose of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject has a body mass index range of 18.5 to 32.0 kg/m^2, inclusive and weighs at least 50 kg at screening.
- Subject has absolute total B cell counts above the lower limit of normal (LLN) reference range measured by flow cytometry at both screening visits 1 and 2. When B cell count reduction (> 50% reduction from the lowest screening baseline value lasting > 6 days postdose in > 4 subjects within a cohort) is observed in a previously enrolled cohort, the subsequent cohorts will enroll only subjects with screening B cell counts above the median of the reference range, as defined by the laboratory.
- Female subject is not pregnant and at least 1 of the following conditions apply:
- Female subject must agree not to breastfeed 90 days prior to screening and throughout the study period and for 90 days after study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period and for 90 days after study drug administration.
Key exclusion criteria (24 listed)
- Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
- Subject has known or suspected hypersensitivity to ASP2713 or any components of the formulation used.
- Subject has had previous exposure with ASP2713.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase and total bilirubin [TBL]) above the upper limit of normal (ULN) at screening visit 1 or on day -2. In such a case, the assessment may be repeated once.
- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic seasonal allergies) 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 |
|---|---|---|
| ASP2713Administered intravenously | Drug | ASP2713 |
| placeboAdministered intravenously | Drug | Placebo |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to 90 days
An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
Number of participants with laboratory value abnormalities and/or adverse events (AEs) [related to treatment]
Time frame: Up to 90 days
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and /or adverse events (AEs) [related to treatment]
Time frame: Up to 90 days
Number of participants with potentially clinically significant vital sign values.
Number of participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs)
Time frame: Up to 90 days
Number of participants with potentially clinically significant ECG values.
Number of participants who develop anti-drug antibodies (ADA) to ASP2713
Time frame: Up to 90 days
Number of participants with presence of ADA will be assessed.
10 secondary outcomes
Pharmacokinetics (PK) of ASP2713 in serum: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to 90 days
PK of ASP2713 in serum: AUC from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to 90 days
PK of ASP2713 in serum: AUC extrapolated from time to infinity as a percentage of total area under the concentration-time curve (AUCinf(%extrap))
Time frame: Up to 90 days
PK of ASP2713 in serum: Maximum concentration (Cmax)
Time frame: Up to 90 days
PK of ASP2713 in serum: Clearance (CL)
Time frame: Up to 90 days
PK of ASP2713 in serum: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
Time frame: Up to 90 days
PK of ASP2713 in serum: Time of the maximum concentration (tmax)
Time frame: Up to 90 days
PK of ASP2713 in serum: Terminal elimination half-life (t1/2)
Time frame: Up to 90 days
PK of ASP2713 in serum: Apparent volume of distribution during the terminal phase (Vz)
Time frame: Up to 90 days
Pharmacodynamics assessed by ASP2713 receptor occupancy
Time frame: Up to 90 days
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 16 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Screening Protocol
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP2713 in people with Healthy Volunteers, run by Astellas Pharma Global Development, Inc..
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 11 inclusion and 24 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 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 with Adverse Events (AEs) (time frame: Up to 90 days). The study lists 5 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 16 Oct 2024.