Acute Coronary SyndromePhase 1NCT04770194
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SP-8008
A Phase 1 study testing SP-8008 Prototype Capsule A and SP-8008 Prototype Capsule B in people with Acute Coronary Syndrome and Stroke, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in United Kingdom.
Trial summary
This is a single-centre, double-blind, randomised, placebo-controlled single oral-dose escalation study in healthy male subjects. It is planned to enrol approximately 48 subjects into up to 6 planned dose level cohorts. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome, Stroke
- What is being tested?
- SP-8008 Prototype Capsule A and SP-8008 Prototype Capsule B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2019to 23 Jan 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age 18 to 55 years of age at the time of signing informed consent
- Body mass index of 18.0 to 32.0 kg/m2 as measured at screening
- Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), electrocardiogram (ECG) and laboratory investigations (haematology, coagulation, clinical chemistry and urinalysis) and bleeding time (bleeding time may be measured on Day 1)
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Who cannot join
- Female subjects
- Subjects who had received any investigator medicinal product (IMP) in a clinical research study within the 3 months or 90 days prior to Day 1
- Subjects who were study site employees, or immediate family members of a study site or sponsor employee
- Subjects who had previously been enrolled in this study
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
Show all 20Show fewer
- Current smokers and those who had smoked within the last 12 months. A confirmed breath carbon monoxide (CO) reading of greater than 10 ppm at screening or admission Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months
- Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months
- Subjects without suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator including investigator medicinal product (PT) >14 s, investigator medicinal product (aPTT) > reference laboratory values, platelet count ≤100,000 mm3, alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) >2× upper limit of normal, white blood cells ≤3000 × 109/L, haemoglobin <11 g/dL, total bilirubin >20 µmol/L, bleeding time >15 min
- Any clinically significant medical disorders increasing the tendency to bleed easily, or a history of recent trauma or surgery, or a history of gout and renal stones
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an estimated Creatinine Clearance (CrCl) of <80 mL/min using the Cockcroft-Gault equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Serious adverse reaction (SAE) or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever was allowed unless it was active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who were taking, or had taken, any prescribed or over-the-counter drug, herbal remedies or supplements in the 14 days before IMP administration; these included fish oil/Omega-3, St. John's wort, ginseng, garlic, gingko, saw palmetto, echinacea, yohimbine, liquorice and black cohosh. Exceptions may have applied on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the principal investigator (PI) and sponsor's medical monitor.
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Nottingham, Nottinghamshire, NG11 6JS
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of SP-8008 in Healthy Male Subjects
This is a single-centre, double-blind, randomised, placebo-controlled single oral-dose escalation study in healthy male subjects. It is planned to enrol approximately 48 subjects into up to 6 planned dose level cohorts.
Subjects will be randomly assigned to receive a single oral dose of active Investigational medicinal product (IMP) or matching placebo in a sequential escalating manner with at least 14 days planned between dose cohorts. Dose review of the preceding dose will take place during the 14 day interval.
The study will consist of escalating single doses in sequential cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive SP-8008 and 2 subjects will receive placebo according to the randomisation schedule. For all dose levels the first 2 sentinel subjects will be randomised 1:1 to placebo or SP-8008, and the remaining 6 subjects will be randomised 1:5 to placebo or SP-8008, respectively.
Read the detailed description
Investigational medicinal product (IMP) will be administered at only 1 dose level at a time. Following each of Periods 1, 2, 3, 4, and 5, there will be a period of interim analysis and review of safety, PK and available PD data from the previous period(s) in order to determine which SP 8008 formulation and dose to administer further regimens. Administration at the next dose level will not begin until the safety and tolerability of the preceding dose level have been evaluated and deemed acceptable by the investigator and sponsor, and the exposure of SP-8008 remains within the pre specified limits following interim review. There will be an interval of no less than 14 days between the dosing of successive cohorts, unless a subject cohort returns to a dose that is lower than that already given in a previous cohort eg to obtain dose linearity information. Dose escalation will be guided by emerging safety, PK and available PD data and confirmed after each interim data review meeting.
There is the option to assess the safety, PK and PD of an alternative formulation. This formulation will be invoked if, following review of data from the preceding periods, it is decided that the exposure from the current formulation may not be ideal for future development.
- Conditions
- Acute Coronary Syndrome, Stroke
- Being tested
- SP-8008 Prototype Capsule A, SP-8008 Prototype Capsule B, Placebo
- Keywords
- antiplatelet drug, shear stress, SP-8008
- Medical subject headings
- Acute Coronary Syndrome, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-8008 Prototype Capsule ADrug
Also called SP-8008
Oral
SP-8008 Prototype Capsule BDrug
Also called SP-8008
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 200mg SP-8008 Prototype Capsule A | Experimental | Treat 200 mg SP-8008 Prototype Capsule A or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. Receives: Drug: SP-8008 Prototype Capsule A; Drug: Placebo |
| Cohort 2: 400mg SP-8008 Prototype Capsule A | Experimental | Treat 400 mg SP-8008 Prototype Capsule A or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. Receives: Drug: SP-8008 Prototype Capsule A; Drug: Placebo |
| Cohort 3: 800mg SP-8008 Prototype Capsule A | Experimental | Treat 800 mg SP-8008 Prototype Capsule A or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. Receives: Drug: SP-8008 Prototype Capsule A; Drug: Placebo |
| Cohort 4: 800 mg SP-8008 Prototype Capsule B | Experimental | Treat 800 mg SP-8008 Capsule B or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. Receives: Drug: SP-8008 Prototype Capsule B; Drug: Placebo |
| Cohort 5: 1200 mg SP-8008 Prototype Capsule B | Experimental | Treat 1200 mg SP-8008 Capsule B or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. Receives: Drug: SP-8008 Prototype Capsule B; Drug: Placebo |
| Cohort 6: 1800 mg SP-8008 Prototype Capsule B | Experimental | Treat 1600 mg SP-8008 Capsule B or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. Receives: Drug: SP-8008 Prototype Capsule B; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with serious adverse drug reactions (SADRs)
The number of subject who experienced a serious adverse drug reaction
Measured: Follows up to 7 days
Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with severe adverse drug reactions (ADRs)
The number of subject who experienced a severe adverse drug reaction
Measured: Follows up to 7 days
Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with clinically significant non-serious adverse events (AEs)
The number of subject who experienced a clinically significant non serious adverse event
Measured: Follows up to 7 days
Secondary outcomes (4)
To evaluate the effect of single dose SP-8008 on platelet function through Shear stress-induced platelet aggregation (SIPA)
Evaluate the pharmacodynamics (PD) effects of SP-8008 to measure platelet functional closure time under SIPA conditions. The effect of SP-8008 on SIPA will be evaluated in anti-coagulated blood with citrate using the Platelet Function Analyser (PFA-100) instrument and optical aggregometry.
Measured: Follows up to 48 hours
To evaluate the effect of single dose SP-8008 on platelet function through inhibition of platelet aggregation (IPA)
Evaluate the PD effects of SP-8008 to investigate the increment of platelet aggravating physiological factors under IPA conditions. The effect of SP-8008 on IPA will be evaluated in anti-coagulated blood with citrate using the Platelet Function Analyser (PFA-100) instrument and optical aggregometry.
Measured: Follows up to 48 hours
To characterize the pharmacokinetics of SP-8008 in health male subjects. - Peak Plasma Concentration (Cmax)
Evaluate Maximum Observed Drug Concentration (Cmax) of SP-8008.
Measured: Follows up to 48 hours
To characterize the pharmacokinetics of SP-8008 in health male subjects. - Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Evaluate Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of SP-8008.
Measured: Follows up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Oct 2019
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be screened for inclusion in the study up to 28 days prior to dosing. Subjects will be admitted to the clinical unit on the morning of Day -1, and will be dosed in a randomised, double-blind manner on the morning of Day 1 following an overnight fast (approximately 10 h). Drug administration will be performed with an appropriate interval (approximately 10 min) between subjects based on logistical requirements. Subjects will remain resident in the clinical unit until up to 48 h after dosing (up to Day 3). Subjects with AEs that represent a cause for concern will be asked to remain resident in the clinical unit until the AE resolves or stabilises. The minimum interval between dose administrations will be 14 days to allow for interim review of PK and safety data from the previous regimen. A follow-up visit will take place 5 to 7 days post-dose for assessment of safety and tolerability.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, MD, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770194
- Sponsor's protocol ID
- SP-8008-1001
- Other IDs
- 2019-000098-21, 2019
- Status last verified
- Feb 2021
- First submitted
- 8 Sep 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of SP-8008 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04770194
- Acronym / sponsor ID
- SP-8008-1001
- Conditions
- Acute Coronary Syndrome, Stroke
- Keywords
- antiplatelet drug, shear stress, SP-8008
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 25 Feb 2021 (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.
This is a single-centre, double-blind, randomised, placebo-controlled single oral-dose escalation study in healthy male subjects. It is planned to enrol approximately 48 subjects into up to 6 planned dose level cohorts.
Subjects will be randomly assigned to receive a single oral dose of active Investigational medicinal product (IMP) or matching placebo in a sequential escalating manner with at least 14 days planned between dose cohorts. Dose review of the preceding dose will take place during the 14 day interval.
The study will consist of escalating single doses in sequential cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive SP-8008 and 2 subjects will receive placebo according to the randomisation schedule. For all dose levels the first 2 sentinel subjects will be randomised 1:1 to placebo or SP-8008, and the remaining 6 subjects will be randomised 1:5 to placebo or SP-8008, respectively.
Detailed description
Investigational medicinal product (IMP) will be administered at only 1 dose level at a time. Following each of Periods 1, 2, 3, 4, and 5, there will be a period of interim analysis and review of safety, PK and available PD data from the previous period(s) in order to determine which SP 8008 formulation and dose to administer further regimens. Administration at the next dose level will not begin until the safety and tolerability of the preceding dose level have been evaluated and deemed acceptable by the investigator and sponsor, and the exposure of SP-8008 remains within the pre specified limits following interim review. There will be an interval of no less than 14 days between the dosing of successive cohorts, unless a subject cohort returns to a dose that is lower than that already given in a previous cohort eg to obtain dose linearity information. Dose escalation will be guided by emerging safety, PK and available PD data and confirmed after each interim data review meeting.
There is the option to assess the safety, PK and PD of an alternative formulation. This formulation will be invoked if, following review of data from the preceding periods, it is decided that the exposure from the current formulation may not be ideal for future development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Subjects will be screened for inclusion in the study up to 28 days prior to dosing. Subjects will be admitted to the clinical unit on the morning of Day -1, and will be dosed in a randomised, double-blind manner on the morning of Day 1 following an overnight fast (approximately 10 h). Drug administration will be performed with an appropriate interval (approximately 10 min) between subjects based on logistical requirements. Subjects will remain resident in the clinical unit until up to 48 h after dosing (up to Day 3). Subjects with AEs that represent a cause for concern will be asked to remain resident in the clinical unit until the AE resolves or stabilises. The minimum interval between dose administrations will be 14 days to allow for interim review of PK and safety data from the previous regimen. A follow-up visit will take place 5 to 7 days post-dose for assessment of safety and tolerability.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 200mg SP-8008 Prototype Capsule A | Experimental | Drug: SP-8008 Prototype Capsule A, Drug: PlaceboTreat 200 mg SP-8008 Prototype Capsule A or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. |
| Cohort 2: 400mg SP-8008 Prototype Capsule A | Experimental | Drug: SP-8008 Prototype Capsule A, Drug: PlaceboTreat 400 mg SP-8008 Prototype Capsule A or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. |
| Cohort 3: 800mg SP-8008 Prototype Capsule A | Experimental | Drug: SP-8008 Prototype Capsule A, Drug: PlaceboTreat 800 mg SP-8008 Prototype Capsule A or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. |
| Cohort 4: 800 mg SP-8008 Prototype Capsule B | Experimental | Drug: SP-8008 Prototype Capsule B, Drug: PlaceboTreat 800 mg SP-8008 Capsule B or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. |
| Cohort 5: 1200 mg SP-8008 Prototype Capsule B | Experimental | Drug: SP-8008 Prototype Capsule B, Drug: PlaceboTreat 1200 mg SP-8008 Capsule B or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. |
| Cohort 6: 1800 mg SP-8008 Prototype Capsule B | Experimental | Drug: SP-8008 Prototype Capsule B, Drug: PlaceboTreat 1600 mg SP-8008 Capsule B or matching placebo. 6 out of 8 subjects were administrated SP-8008 and the other two were received Placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males
- Age 18 to 55 years of age at the time of signing informed consent
- Body mass index of 18.0 to 32.0 kg/m2 as measured at screening
- Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination), electrocardiogram (ECG) and laboratory investigations (haematology, coagulation, clinical chemistry and urinalysis) and bleeding time (bleeding time may be measured on Day 1)
- Must be willing and able to communicate and participate in the whole study
Key exclusion criteria (20 listed)
- Female subjects
- Subjects who had received any investigator medicinal product (IMP) in a clinical research study within the 3 months or 90 days prior to Day 1
- Subjects who were study site employees, or immediate family members of a study site or sponsor employee
- Subjects who had previously been enrolled in this study
- History of any drug or alcohol abuse in the past 2 years
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 |
|---|---|---|
| SP-8008 Prototype Capsule AAlso: SP-8008Oral | Drug | Cohort 1: 200mg SP-8008 Prototype Capsule A, Cohort 2: 400mg SP-8008 Prototype Capsule A, Cohort 3: 800mg SP-8008 Prototype Capsule A |
| SP-8008 Prototype Capsule BAlso: SP-8008Oral | Drug | Cohort 4: 800 mg SP-8008 Prototype Capsule B, Cohort 5: 1200 mg SP-8008 Prototype Capsule B, Cohort 6: 1800 mg SP-8008 Prototype Capsule B |
| PlaceboOral | Drug | Cohort 1: 200mg SP-8008 Prototype Capsule A, Cohort 2: 400mg SP-8008 Prototype Capsule A, Cohort 3: 800mg SP-8008 Prototype Capsule A, Cohort 4: 800 mg SP-8008 Prototype Capsule B, Cohort 5: 1200 mg SP-8008 Prototype Capsule B, Cohort 6: 1800 mg SP-8008 Prototype Capsule B |
Primary outcome
Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with serious adverse drug reactions (SADRs)
Time frame: Follows up to 7 days
The number of subject who experienced a serious adverse drug reaction
Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with severe adverse drug reactions (ADRs)
Time frame: Follows up to 7 days
The number of subject who experienced a severe adverse drug reaction
Safety profile of single doses of SP-8008 in healthy male subjects was evaluated with clinically significant non-serious adverse events (AEs)
Time frame: Follows up to 7 days
The number of subject who experienced a clinically significant non serious adverse event
4 secondary outcomes
To evaluate the effect of single dose SP-8008 on platelet function through Shear stress-induced platelet aggregation (SIPA)
Time frame: Follows up to 48 hours
To evaluate the effect of single dose SP-8008 on platelet function through inhibition of platelet aggregation (IPA)
Time frame: Follows up to 48 hours
To characterize the pharmacokinetics of SP-8008 in health male subjects. - Peak Plasma Concentration (Cmax)
Time frame: Follows up to 48 hours
To characterize the pharmacokinetics of SP-8008 in health male subjects. - Area under the plasma concentration versus time curve from time zero to infinity (AUC[0-∞])
Time frame: Follows up to 48 hours
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 25 Feb 2021.
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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.
Stuart Mair, MD principal investigator
Quotient Sciences
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 SP-8008 Prototype Capsule A and SP-8008 Prototype Capsule B in people with Acute Coronary Syndrome and Stroke, run by Shin Poong Pharmaceutical Co. Ltd. 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 7 inclusion and 20 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 25 Feb 2021. 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 profile of single doses of SP-8008 in healthy male subjects was evaluated with serious adverse drug reactions (SADRs) (time frame: Follows up to 7 days). The study lists 3 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 25 Feb 2021.