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Pharmacokinetics of ASKP1240Phase 1NCT01565681

Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects

A Phase 1 study testing ASP1240 in people with Pharmacokinetics of ASKP1240 and Healthy Volunteers, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
ASP1240
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
1 siteUnited States
Study dates
Jan 2009to Dec 2009
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
  • The female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L)
  • Male subject agrees to no sperm donation until end of study or 90 days post dose, whichever is longer
  • The subject is highly likely to comply with the protocol and complete the study
  • The subject has a negative urine screen for drugs of abuse, and negative blood or breathalyzer alcohol screen at Screening and clinic admission on Day 1

Who cannot join

  • The subject has a history of severe allergic or anaphylactic reactions
  • The subject has 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 prior to screening (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits)
  • 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
  • The subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or pulse rate higher than 100 beats per min (bpm), either at screening or clinic check in (blood pressure measurements taken in triplicate after subject has been resting in a supine position for a minimum of 5 minutes)
  • The subject is known positive for human immunodeficiency virus (HIV) antibody
  • The subject has a positive test for hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg)
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  • The subject has at screening or clinic check in that:
  • white blood cell count (WBC) is < 3.5 or > upper limit of normal
  • absolute neutrophil count (ANC) is <1.5 or > upper limit of normal
  • platelet count (PLT) is outside the normal limit
  • serum creatinine, total bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) are > upper limit of normal
  • creatine phosphokinase (CPK) is > two times upper limit of normal
  • international normalized ratio (INR) is > upper limit of normal
  • OR remaining laboratory tests are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per protocol laboratory tests
  • The subject has received a vaccine within 60 days prior to study drug administration
  • The subject has received any systemic immunosuppressant agent within 6 months prior to study drug administration.
  • The subject has received any antibody or biologic product within 6 months prior to study drug administration
  • The subject has received any systemic steroid within 2 months prior to study drug administration
  • The subject has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines (CAM) and excluding over-the-counter (OTC) allergy medications, nasal steroids, nasal inhalers, oral contraceptives, stable hormone replacement therapy (HRT; per Investigator judgment and dose change not expected during study), and intermittent acetaminophen, within 14 days prior to study drug administration
  • The subject has received an experimental agent within 30 days or ten 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 donated or has had significant blood loss or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to dosing
  • 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 prior to Screening
  • The subject has a history of thromboembolic or vascular disease especially deep vein thrombosis, pulmonary embolism and varices
  • The subject has a positive test for tuberculosis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Parexel

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Phase 1 Single Ascending Dose Study of ASKP1240 in Healthy Male and Female Volunteers

The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.

Being tested
ASP1240, Placebo
Keywords
Healthy Volunteers, B cell CD40 receptor occupancy, anti-CD40 monoclonal antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASP1240Drug

    infusion

  • PlaceboDrug

    Also called Sodium Chloride solution

    infusion

Study groups in NCT01565681
Study groupRoleWhat they receive
Arm A: ASKP1240 lowest doseExperimentalNot described
Receives: Drug: ASP1240
Arm B: ASKP1240 second lowest doseExperimentalNot described
Receives: Drug: ASP1240
Arm C: ASKP1240 third lowest doseExperimentalNot described
Receives: Drug: ASP1240
Arm D: ASKP1240 fourth lowest doseExperimentalNot described
Receives: Drug: ASP1240
Arm E: ASKP1240 fifth lowest doseExperimentalNot described
Receives: Drug: ASP1240
Arm F: ASKP1240 middle doseExperimentalNot described
Receives: Drug: ASP1240
Arm G: ASKP1240 sixth highest doseExperimentalNot described
Receives: Drug: ASP1240
Arm H: ASKP1240 fifth highest doseExperimentalNot described
Receives: Drug: ASP1240
Arm I: ASKP1240 fourth highest doseExperimentalNot described
Receives: Drug: ASP1240
Arm J: ASKP1240 third highest doseExperimentalNot described
Receives: Drug: ASP1240
Arm K: ASKP1240 second highest doseExperimentalNot described
Receives: Drug: ASP1240
Arm L: ASKP1240 highest doseExperimentalNot described
Receives: Drug: ASP1240
Arm M: PlaceboPlacebo comparatorSodium Chloride solution
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacodynamic variable: Individual subject cell surface antigen (CD40) occupancy levels over time

    binding of ASKP1240-biotin to B cells

    Measured: Days 1-3, 5, 8,15, 22, 29, 43, 60, 75, and 90

  2. Pharmacokinetics profile: AUCinf and Cmax

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) and Maximum concentration of study drug (Cmax)

    Measured: Days 1-8,15, 22, 29, 43 and 60

Secondary outcomes (4)

  1. Pharmacokinetics profile: AUClast, tmax, t1/2, Vz, and CLtot

    Area under the plasma concentration-time curve from time 0 up to the last quantifiable concentration (AUClast),Time to attain Cmax (tmax), Apparent terminal elimination of half-life (t1/2), Apparent volume of distribution ( Vz), and Total body clearance (CLtot)

    Measured: Days 1-8,15, 22, 29, 43 and 60

  2. Total lymphocyte count

    product of the white blood count (WBC) and percent lymphocytes [from differential]

    Measured: Day -1, Days 1-3, 5, 8,15, 22, 29, 43, and 60

  3. Peripheral lymphocyte subset quantification

    leukocycte phenotypes: CD3, CD4, CD8,CD16, and CD20

    Measured: Day -1, Days 1-3, 5, 8,15, 22, 29, 43, and 60

  4. Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs), physical examination, pulse oximetry, and incidence of anti-ASKP1240 antibody formation

    Measured: Up to day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2012 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

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
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01565681
Sponsor's protocol ID
7163-CL-0101
Status last verified
Dec 2012
First submitted
27 Mar 2012
Last updated
10 Dec 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP1240 in people with Pharmacokinetics of ASKP1240 and Healthy Volunteers, 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 25 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 10 Dec 2012. 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?

Pharmacodynamic variable: Individual subject cell surface antigen (CD40) occupancy levels over time (time frame: Days 1-3, 5, 8,15, 22, 29, 43, 60, 75, and 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01565681.

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 10 Dec 2012.

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