Healthy SubjectsPhase 1NCT02681861
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects
A Phase 1 study testing ASP6294 Intravenous and ASP6294 Subcutaneous in people with Healthy Subjects and Pharmacokinetics of ASP6294, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and female subjects. 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 ASP6294
- What is being tested?
- ASP6294 Intravenous and ASP6294 Subcutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Dec 2016
- 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 - 30.0 kg/m2, inclusive, and the subject weighs at least 50 kg (at screening).
- Female subject must either:
- Be of non-childbearing potential: Post-menopausal (defined as at least 1 year without any menses) prior to screening, or Documented surgically sterile
- Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 120 days after final study drug administration; Must have a negative pregnancy test at screening and day -1; And, if heterosexually active, agree to consistently use 2 forms of birth control starting at screening and throughout the clinical study period and for 120 days after final study drug administration.
- Female subject must agree not to breastfeed starting at screening and throughout the clinical study period, and for 120 days after final study drug administration.
- Female subject must not donate ova starting at screening and throughout the clinical study period, and for 120 days after final study drug administration.
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- Male subject and their female spouse/partner who are of childbearing potential must be using a highly effective form of birth control† in combination with a barrier method starting at screening and throughout the clinical study period and for 120 days after final study drug administration.
- Male subject must not donate sperm starting at screening and throughout the clinical study period and for 120 days after final study drug administration.
- Subject agrees not to participate in another interventional study during participation in the present study, defined as signing 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 assessment or breast feeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP6294 or any components of the formulation used.
- Subject has been exposed to a biological drug within the last 6 months prior to screening.
- Subject has a history of allergic or anaphylactic reaction to a biological drug.
- Subject has been diagnosed with osteoarthritis (OA) or has a history of rapidly progressive OA.
- Subject has any of the liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, gamma glutamyl transferase, total bilirubin [TBL]) above the upper limit of normal (ULN) at day-1. In such a case, the assessment may be repeated once.
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- Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (including orthostatic hypotension and autonomic neuropathy), dermatologic, psychiatric, renal and/or other major disease or malignancy, as judged by the investigator.
- Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (noncutaneous) infection within 1 week prior to day -1 (admission day).
- Subject has any clinically significant abnormality following the investigator's review of the physical examination, ECG and protocol-defined clinical laboratory tests at screening or day -1.
- Subject has a mean pulse < 40 or > 90 beats per minute; mean systolic blood pressure > 140 mmHg; mean diastolic blood pressure > 90 mmHg (vital sign measurements taken in triplicate after subject has been resting in supine position for 5 minutes; pulse will be measured automatically) at screening and day -1. 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 ms for males and > 450 ms for females at screening and day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken (admission day).
- Subject uses any prescribed or nonprescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration, except for occasional use of paracetamol (up to 2 g/day) or the use of contraceptives or hormone replacement therapy.
- Subject has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the clinical unit.
- Subject has a history of drinking more than 21 units (male subjects) or 14 units (female subjects) of alcohol per week (1 unit = 10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 100 mL of wine [12%]) within 3 months prior to admission to the clinical unit or the subject tests positive for alcohol or drugs of abuse at screening or day-1 (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinoids, cocaine, and opiates).
- Subject uses any drugs of abuse within 3 months prior to admission to the clinical unit.
- Subject uses any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the clinical unit regularly.
- Subject has experienced 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 clinic admission to the clinical unit.
- 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 types 1 and 2.
- Subject participated in any clinical study or has been treated with any investigational drugs within 3 months prior to screening.
- Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation, such as phobias for intravenous or subcutaneous needles/injections.
- Subject is an employee of the Astellas Group or a contract research organization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects
The purpose of this study is to evaluate the safety and tolerability of single ascending intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and female subjects.
This study will also evaluate the pharmacokinetics (pk) of single ascending intravenous doses and single ascending sc doses of ASP6294; determine the effect of ASP6294 administered intravenously and sc on the serum levels of circulating total Nerve Growth Factor (NGF); explore a potential gender difference in safety, tolerability and pk of single intravenous dose and single sc doses administrations of ASP6294 as well as determine the maximum tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294.
Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc.
Read the detailed description
The study consists of two parts: Part 1 (ascending intravenous dose) and Part 2 (ascending subcutaneous dose). Subjects will participate in either Part 1 or Part 2. Subjects in Part 1 and Part 2 will have a residential period of 6 days followed by outpatient visits.
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP6294
- Being tested
- ASP6294 Intravenous, ASP6294 Subcutaneous, Placebo Intravenous, Placebo Subcutaneous
- Keywords
- Pharmacodynamics, Pharmacokinetics, ASP6294, Maximum tolerated dose, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP6294 IntravenousDrug
Intravenous (IV)
ASP6294 SubcutaneousDrug
Subcutaneous (SC)
Placebo IntravenousDrug
Intravenous (IV)
Placebo SubcutaneousDrug
Subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ASP6294 Single Ascending Intravenous Doses | Experimental | A dose escalation design will be implemented. Successive cohorts of patients (8 participants/cohort) will each be started on a fixed dose of ASP6294 or Placebo intravenously. If no dose limiting toxicities are observed escalation to the next higher dose is planned approximately every 3 weeks. Within the planned dose range, a dose lower than the next planned dose may be tested, or a dose level may be repeated, depending on emerging safety, tolerability and/or other relevant data, such as available pharmacokinetic and pharmacodynamic data of previous dose levels. Receives: Drug: ASP6294 Intravenous; Drug: Placebo Intravenous |
| Part 2: ASP6294 Single Ascending Subcutaneous Doses | Experimental | A dose escalation design will be implemented. Successive cohorts of patients (8 participants/cohort) will each be started on a fixed dose of ASP6294 or Placebo subcutaneously. The subcutaneous cohorts may be done in parallel with part 1, using doses which have been proven to be safe and tolerable. Within the planned dose range, a dose lower than the next planned dose may be tested, or a dose level may be repeated, depending on emerging safety, tolerability and/or other relevant data, such as available pharmacokinetic and pharmacodynamic data of previous dose levels. Receives: Drug: ASP6294 Subcutaneous; Drug: Placebo Subcutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ASP6294 as assessed by Nature, frequency and severity of Adverse Events (AEs)
Measured: Up to 120 Days
Safety of ASP6294 as assessed by Vital signs
Vital signs include blood pressure, pulse and oral body temperature
Measured: Up to 120 Days
Safety of ASP6294 as assessed by Neurological examination
Neurological Assessment will be measured on a scale for the following Neurological examinations: Gait; Coordination; Speech; Cranial Nerves; Sensations; Muscle Strength; Muscle Tone; Muscle Movement and Reflexes and will be rated as "Normal" or "Abnormal".
Measured: Up to 120 Days
Safety of ASP6294 as assessed by laboratory tests
Laboratory tests include hematology, biochemistry and urinalysis
Measured: Up to 120 Days
Safety of ASP6294 as assessed by routine 12-lead Electrocardiogram (ECG)
Measured: Up to 120 Days
Safety of ASP6294 as assessed by continuous cardiac monitoring (Holter ECG) (part 1 only)
ECGs are to be collected using a 12-lead ECG continuous monitoring and recording system.
Measured: Days 1 and 2
Safety of ASP6294 as assessed by Sensory assessments
Sensory Assessment will be measured on a scale for Lower Limbs and Hands. The following categories: Touch Pressure; Pinprick; Vibration and Joint Position will be rated as Normal (=0 points), Decreased (= 1 point) or Absent (=2 points). A total score for the left and right side of lower limbs and hands will be calculated.
Measured: Up to 120 Days
Secondary outcomes (15)
Pharmacokinetics of ASP6294: AUClast
Area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: AUC168h
Area under the concentration-time curve from the time of dosing to 168 hours postdose (AUC168h)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: AUCinf
Area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: Cmax
Maximum concentration (Cmax)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: CL (part 1 only)
Total systemic clearance after intravenous dosing (CL)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: CL/F (part 2 only)
Apparent total systemic clearance after extravascular dosing (CL/F)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: λz
Terminal elimination rate constant (λz)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: MRT
Mean residence time (MRT)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: tmax
Time of maximum concentration (tmax)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: t1/2
Terminal elimination half-life (t1/2)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: Vss (part 1 only)
Volume of distribution at steady state determined after intravenous dosing (Vss)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: Vz (part 1 only)
Volume of distribution during terminal elimination phase after intravenous dosing (Vz)
Measured: Up to 120 Days
Pharmacokinetics of ASP6294: Vz/F (part 2 only)
Apparent volume of distribution during the terminal elimination phase after extravascular dosing (Vz/F)
Measured: Up to 120 Days
Pharmacodynamics of ASP6294 Nerve growth factor (NGF) total serum concentration: Cmax
Measured: Up to 120 Days
Pharmacodynamics of ASP6294 NGF total serum concentration: tmax
Measured: Up to 120 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681861
- Sponsor's protocol ID
- 6294-CL-0001
- Other IDs
- 2014-003451-59, 2014
- Status last verified
- Jan 2017
- First submitted
- 21 Jan 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP6294 Administered Intravenously or Subcutaneously in Healthy Young Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02681861
- Acronym / sponsor ID
- 6294-CL-0001
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP6294
- Keywords
- Pharmacodynamics, Pharmacokinetics, ASP6294, Maximum tolerated dose, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Feb 2016 (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 evaluate the safety and tolerability of single ascending intravenous doses and single subcutaneous (sc) doses of ASP6294 in healthy young male and female subjects.
This study will also evaluate the pharmacokinetics (pk) of single ascending intravenous doses and single ascending sc doses of ASP6294; determine the effect of ASP6294 administered intravenously and sc on the serum levels of circulating total Nerve Growth Factor (NGF); explore a potential gender difference in safety, tolerability and pk of single intravenous dose and single sc doses administrations of ASP6294 as well as determine the maximum tolerated dose (MTD) of single intravenous doses and single sc doses of ASP6294.
Part 2 will also evaluate the relative bioavailability of ASP6294 when administered sc.
Detailed description
The study consists of two parts: Part 1 (ascending intravenous dose) and Part 2 (ascending subcutaneous dose). Subjects will participate in either Part 1 or Part 2. Subjects in Part 1 and Part 2 will have a residential period of 6 days followed by outpatient visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: ASP6294 Single Ascending Intravenous Doses | Experimental | Drug: ASP6294 Intravenous, Drug: Placebo IntravenousA dose escalation design will be implemented. Successive cohorts of patients (8 participants/cohort) will each be started on a fixed dose of ASP6294 or Placebo intravenously. If no dose limiting toxicities are observed escalation to the next higher dose is planned approximately every 3 weeks. Within the planned dose range, a dose lower than the next planned dose may be tested, or a dose level may be repeated, depending on emerging safety, tolerability and/or other relevant data, such as available pharmacokinetic and pharmacodynamic data of previous dose levels. |
| Part 2: ASP6294 Single Ascending Subcutaneous Doses | Experimental | Drug: ASP6294 Subcutaneous, Drug: Placebo SubcutaneousA dose escalation design will be implemented. Successive cohorts of patients (8 participants/cohort) will each be started on a fixed dose of ASP6294 or Placebo subcutaneously. The subcutaneous cohorts may be done in parallel with part 1, using doses which have been proven to be safe and tolerable. Within the planned dose range, a dose lower than the next planned dose may be tested, or a dose level may be repeated, depending on emerging safety, tolerability and/or other relevant data, such as available pharmacokinetic and pharmacodynamic data of previous dose levels. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject has a body mass index range of 18.5 - 30.0 kg/m2, inclusive, and the subject weighs at least 50 kg (at screening).
- Female subject must either:
- Female subject must agree not to breastfeed starting at screening and throughout the clinical study period, and for 120 days after final study drug administration.
- Female subject must not donate ova starting at screening and throughout the clinical study period, and for 120 days after final study drug administration.
- Male subject and their female spouse/partner who are of childbearing potential must be using a highly effective form of birth control† in combination with a barrier method starting at screening and throughout the clinical study period and for 120 days after final study drug administration.
Key exclusion criteria (22 listed)
- Female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
- Subject has a known or suspected hypersensitivity to ASP6294 or any components of the formulation used.
- Subject has been exposed to a biological drug within the last 6 months prior to screening.
- Subject has a history of allergic or anaphylactic reaction to a biological drug.
- Subject has been diagnosed with osteoarthritis (OA) or has a history of rapidly progressive OA.
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 |
|---|---|---|
| ASP6294 IntravenousIntravenous (IV) | Drug | Part 1: ASP6294 Single Ascending Intravenous Doses |
| ASP6294 SubcutaneousSubcutaneous (SC) | Drug | Part 2: ASP6294 Single Ascending Subcutaneous Doses |
| Placebo IntravenousIntravenous (IV) | Drug | Part 1: ASP6294 Single Ascending Intravenous Doses |
| Placebo SubcutaneousSubcutaneous (SC) | Drug | Part 2: ASP6294 Single Ascending Subcutaneous Doses |
Primary outcome
Safety of ASP6294 as assessed by Nature, frequency and severity of Adverse Events (AEs)
Time frame: Up to 120 Days
Safety of ASP6294 as assessed by Vital signs
Time frame: Up to 120 Days
Vital signs include blood pressure, pulse and oral body temperature
Safety of ASP6294 as assessed by Neurological examination
Time frame: Up to 120 Days
Neurological Assessment will be measured on a scale for the following Neurological examinations: Gait; Coordination; Speech; Cranial Nerves; Sensations; Muscle Strength; Muscle Tone; Muscle Movement and Reflexes and will be rated as "Normal" or "Abnormal".
Safety of ASP6294 as assessed by laboratory tests
Time frame: Up to 120 Days
Laboratory tests include hematology, biochemistry and urinalysis
Safety of ASP6294 as assessed by routine 12-lead Electrocardiogram (ECG)
Time frame: Up to 120 Days
Safety of ASP6294 as assessed by continuous cardiac monitoring (Holter ECG) (part 1 only)
Time frame: Days 1 and 2
ECGs are to be collected using a 12-lead ECG continuous monitoring and recording system.
Safety of ASP6294 as assessed by Sensory assessments
Time frame: Up to 120 Days
Sensory Assessment will be measured on a scale for Lower Limbs and Hands. The following categories: Touch Pressure; Pinprick; Vibration and Joint Position will be rated as Normal (=0 points), Decreased (= 1 point) or Absent (=2 points). A total score for the left and right side of lower limbs and hands will be calculated.
15 secondary outcomes
Pharmacokinetics of ASP6294: AUClast
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: AUC168h
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: AUCinf
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: Cmax
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: CL (part 1 only)
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: CL/F (part 2 only)
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: λz
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: MRT
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: tmax
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: t1/2
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: Vss (part 1 only)
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: Vz (part 1 only)
Time frame: Up to 120 Days
Pharmacokinetics of ASP6294: Vz/F (part 2 only)
Time frame: Up to 120 Days
Pharmacodynamics of ASP6294 Nerve growth factor (NGF) total serum concentration: Cmax
Time frame: Up to 120 Days
Pharmacodynamics of ASP6294 NGF total serum concentration: tmax
Time frame: Up to 120 Days
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 10 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Executive Director study director
Astellas Pharma Europe B.V.
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 ASP6294 Intravenous and ASP6294 Subcutaneous in people with Healthy Subjects and Pharmacokinetics of ASP6294, run by Astellas Pharma Europe B.V. at 1 site in United Kingdom.
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 9 inclusion and 22 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 Jan 2017. 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 Kingdom. 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. 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?
Safety of ASP6294 as assessed by Nature, frequency and severity of Adverse Events (AEs) (time frame: Up to 120 Days). The study lists 7 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 10 Jan 2017.