Alzheimer's DiseasePhase 1NCT03838185
Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147
A Phase 1 study testing J147 in people with Alzheimer's Disease, run by Abrexa Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects. The study will include single ascending dose (SAD) in healthy young and elderly subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- J147
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 1 Feb 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide voluntarily agreement to participate in this study and signs an IRB/IEC-approved informed consent prior to performing any of the screening procedures
- Healthy male subjects, between 18 to 50 years of age, inclusive, at the time of signing the informed consent; OR, Healthy male and female subjects, between 60 to 85 years of age, inclusive, at the time of signing the informed consent
- If male, subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or agree to use a highly effective contraception method during the intervention period and for at least 3 months after the last dose of study medication and refrain from donating sperm during this period. Because of the unacceptable failure rate of barrier (chemical and/or physical) methods, the barrier method of contraception must only be used in combination with a highly effective method. Post coital methods of contraception are not permitted.
- If female, must not be pregnant, must not be lactating, and must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or postmenopausal ≥ 1 year.
- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening with a weight of at least 50 kg
- Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past year) and by urine cotinine concentration (< 200 ng/mL) at the screening visit and admission
Who cannot join
- Has clinically significant history or evidence of cardiovascular, endocrine, hematologic, immune, gastrointestinal, genitourinary or other body system disease as determined by an Investigator
- Has clinically significant history or evidence of disease or dysfunction in neurological or psychiatric system that is likely to affect the results of the study in the opinion of an Investigator
- Has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs
- Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study
- Has positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or human immunodeficiency virus (HIV) antibodies
- Has a urine blood test for ethanol or cotinine at the screening visit or admission
Show all 23Show fewer
- Has a positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) at the screening visit or admission
- Females who are breastfeeding
- Is unwilling to or has not avoided consumption of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges within 14 days of dosing with study medication
- Has history of alcohol and/or illicit drug abuse within 1 year of entry or is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical unit
- Has donated blood (> 500 mL) or blood products within 30 days prior to first day of dosing
- Requires treatment with any medication, prescription or over-the-counter (OTC) medications (including vitamins [mega doses], dietary supplements or herbal medications), prescription medications within 14 days prior to administration of study medication. By exception, acetaminophen ≤ 1000 mg per day and vitamin products at recommended daily doses are permitted
- Has received any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines or herbal/plant-derived preparations such as St. John's wort) for a period of 30 days prior to dosing
- Has used an investigational drug within 30 days prior to screening
- Has a history of hypersensitivity or allergies to J147, any components of formulated J147, or any drug within the same class; minor drug allergies to a drug in another drug class may be approved by an Investigator if not considered of clinical relevance
- Has clinically significant abnormal vital signs, 12-lead ECGs, physical examination, clinical laboratory, or other safety variable, as judged by an Investigator
- Is considering or has scheduled any surgical procedure during study participation
- Requires a special diet or has a significant food allergy or intolerance; if the subject or patient is vegetarian, he or she may be enrolled at an Investigator's discretion
- Is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study
- Is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study
- Has previously been enrolled in this clinical study or is currently enrolled in another clinical study
- For the elderly subjects, there must be no evidence of cognitive decline that has been greater than expected for age and no evidence of changes in their level of independence in everyday life.
- Is judged by an Investigator or Sponsor to be inappropriate for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66206
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147 in Healthy Young Volunteers and Healthy Elderly Volunteers
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects. The study will include single ascending dose (SAD) in healthy young and elderly subjects.
Read the detailed description
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects and to perform a preliminary assessment of the effect of food on safety and PK parameters of J147. The study will include single ascending dose (SAD) in healthy young and elderly subjects.
Approximately 64 subjects may be included in the study, with an additional 24 to be added depending on the emerging data.
Six cohorts of 8 healthy young male subjects and 2 cohorts of 8 healthy elderly male and female subjects are planned. Depending on emerging safety, tolerability and PK data, 2 additional cohorts of 8 healthy young male subjects in each cohort and 1 additional cohort of 8 elderly male and female subjects may be enrolled.
In each cohort, 6 subjects will be randomized to receive a single dose of J147 orally and 2 subjects will be randomized to receive a matching dose of placebo.
All cohorts will consist of 2 sentinel subjects of whom 1 subject will receive J147 and 1 subject will receive matching placebo. The remaining 6 subjects of whom 5 subjects will receive J147 and 1 subject will receive matching placebo will be dosed at least 24 hours following the sentinel subjects.
Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.
- Conditions
- Alzheimer's Disease
- Being tested
- J147, Placebo
- Keywords
- Dementia, Neurodegenerative Disease
- Medical subject headings
- Alzheimer Disease, Dementia, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J147Drug
Single oral dose of J147
PlaceboDrug
Single oral dose of corn oil
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Experimental | Healthy young male subjects will receive a single ascending oral dose of J147 following an overnight fast of at least 8 hours. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects. Receives: Drug: J147 |
| Placebo | Placebo comparator | Subjects will receive a single oral dose of placebo with 240 mL non-carbonated water in the morning following an overnight fast of at least 8 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Nature, frequency and severity of adverse events
Measured: from pre-dose to 7+/-2 days post dose
Number of subjects with abnormal electrocardiogram
12-lead electrocardiogram measurement
Measured: from pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in serum biomarker levels in a standard serum chemistry panel
Changes in standard serum chemistry measures will be assessed.
Measured: from pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in hematological biomarker levels in a standard hematology panel
Changes in standard hematology measures will be assessed.
Measured: from pre-dose to 7+/-2 days post dose
Incidence of clinically significant changes in urine biomarker levels in a standard urinalysis panel
Changes in standard urinalysis measures will be assessed.
Measured: from pre-dose to 7+/-2 days post dose
Number of patients exhibiting changes in standard Physical Examination results
Measured: from pre-dose to 7+/-2 days post dose
Number of patients exhibiting changes in standard Neurological Examination results
Measured: from pre-dose to 7+/-2 days post dose
Secondary outcomes (7)
Maximum plasma concentration (Cmax)
Measured: 0-48 hours post dose
Time to Cmax (Tmax)
Measured: 0-48 hours post dose
Area under the plasma concentration vs. time curve (AUC)
Measured: 0-48 hours post dose
Terminal rate constant
Measured: 0-48 hours post dose
Terminal half-life (t1/2)
Measured: 0-48 hours post dose
Apparent plasma clearance (CL/F)
Measured: 0-48 hours post dose
Renal clearance (CLr)
Measured: 0-48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start22 Jan 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies 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
- Sequential
- Model description
- Subjects will receive a single dose of J147 or placebo in a fasted state. The dose levels are planned to be administered in ascending order. Progression to the next dose level, and dose selection, will be based on all available safety and tolerability data up to at least 48 hours post-dose and available PK data (up to at least 24 hours post-dose) from a minimum of 6 subjects (J147 n ≥4) in the preceding dose cohort. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abrexa Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Martin Kankam, MD, PhD, MPH, Principal investigator, Vince & Associates Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838185
- Sponsor's protocol ID
- ABRJ147001
- Status last verified
- Sep 2020
- First submitted
- 7 Feb 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen Q, Prior M, Dargusch R, Roberts A, Riek R, Eichmann C, Chiruta C, Akaishi T, Abe K, Maher P, Schubert D. A novel neurotrophic drug for cognitive enhancement and Alzheimer's disease. PLoS One. 2011;6(12):e27865. doi: 10.1371/journal.pone.0027865. Epub 2011 Dec 14.
PubMed 22194796Prior M, Dargusch R, Ehren JL, Chiruta C, Schubert D. The neurotrophic compound J147 reverses cognitive impairment in aged Alzheimer's disease mice. Alzheimers Res Ther. 2013 May 14;5(3):25. doi: 10.1186/alzrt179. eCollection 2013.
PubMed 23673233Currais A, Goldberg J, Farrokhi C, Chang M, Prior M, Dargusch R, Daugherty D, Armando A, Quehenberger O, Maher P, Schubert D. A comprehensive multiomics approach toward understanding the relationship between aging and dementia. Aging (Albany NY). 2015 Nov;7(11):937-55. doi: 10.18632/aging.100838.
PubMed 26564964Prior M, Goldberg J, Chiruta C, Farrokhi C, Kopynets M, Roberts AJ, Schubert D. Selecting for neurogenic potential as an alternative for Alzheimer's disease drug discovery. Alzheimers Dement. 2016 Jun;12(6):678-86. doi: 10.1016/j.jalz.2016.03.016. Epub 2016 May 2.
PubMed 27149904Goldberg J, Currais A, Prior M, Fischer W, Chiruta C, Ratliff E, Daugherty D, Dargusch R, Finley K, Esparza-Molto PB, Cuezva JM, Maher P, Petrascheck M, Schubert D. The mitochondrial ATP synthase is a shared drug target for aging and dementia. Aging Cell. 2018 Apr;17(2):e12715. doi: 10.1111/acel.12715. Epub 2018 Jan 7.
PubMed 29316249
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147 in Healthy Young Volunteers and Healthy Elderly Volunteers
- ClinicalTrials.gov ID
- NCT03838185
- Acronym / sponsor ID
- ABRJ147001
- Conditions
- Alzheimer's Disease
- Keywords
- Dementia, Neurodegenerative Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Abrexa Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 12 Feb 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.
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects. The study will include single ascending dose (SAD) in healthy young and elderly subjects.
Detailed description
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects and to perform a preliminary assessment of the effect of food on safety and PK parameters of J147. The study will include single ascending dose (SAD) in healthy young and elderly subjects.
Approximately 64 subjects may be included in the study, with an additional 24 to be added depending on the emerging data.
Six cohorts of 8 healthy young male subjects and 2 cohorts of 8 healthy elderly male and female subjects are planned. Depending on emerging safety, tolerability and PK data, 2 additional cohorts of 8 healthy young male subjects in each cohort and 1 additional cohort of 8 elderly male and female subjects may be enrolled.
In each cohort, 6 subjects will be randomized to receive a single dose of J147 orally and 2 subjects will be randomized to receive a matching dose of placebo.
All cohorts will consist of 2 sentinel subjects of whom 1 subject will receive J147 and 1 subject will receive matching placebo. The remaining 6 subjects of whom 5 subjects will receive J147 and 1 subject will receive matching placebo will be dosed at least 24 hours following the sentinel subjects.
Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will receive a single dose of J147 or placebo in a fasted state. The dose levels are planned to be administered in ascending order. Progression to the next dose level, and dose selection, will be based on all available safety and tolerability data up to at least 48 hours post-dose and available PK data (up to at least 24 hours post-dose) from a minimum of 6 subjects (J147 n ≥4) in the preceding dose cohort. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects.
| Arm | Type | Receives |
|---|---|---|
| Study Drug | Experimental | Drug: J147Healthy young male subjects will receive a single ascending oral dose of J147 following an overnight fast of at least 8 hours. Healthy elderly subjects will receive doses that have been found to be safe in healthy young subjects. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a single oral dose of placebo with 240 mL non-carbonated water in the morning following an overnight fast of at least 8 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide voluntarily agreement to participate in this study and signs an IRB/IEC-approved informed consent prior to performing any of the screening procedures
- Healthy male subjects, between 18 to 50 years of age, inclusive, at the time of signing the informed consent; OR, Healthy male and female subjects, between 60 to 85 years of age, inclusive, at the time of signing the informed consent
- If male, subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or agree to use a highly effective contraception method during the intervention period and for at least 3 months after the last dose of study medication and refrain from donating sperm during this period. Because of the unacceptable failure rate of barrier (chemical and/or physical) methods, the barrier method of contraception must only be used in combination with a highly effective method. Post coital methods of contraception are not permitted.
- If female, must not be pregnant, must not be lactating, and must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or postmenopausal ≥ 1 year.
- Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening with a weight of at least 50 kg
Key exclusion criteria (23 listed)
- Has clinically significant history or evidence of cardiovascular, endocrine, hematologic, immune, gastrointestinal, genitourinary or other body system disease as determined by an Investigator
- Has clinically significant history or evidence of disease or dysfunction in neurological or psychiatric system that is likely to affect the results of the study in the opinion of an Investigator
- Has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs
- Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study
- Has positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or human immunodeficiency virus (HIV) antibodies
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 |
|---|---|---|
| J147Single oral dose of J147 | Drug | Study Drug |
| PlaceboSingle oral dose of corn oil | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: from pre-dose to 7+/-2 days post dose
Nature, frequency and severity of adverse events
Number of subjects with abnormal electrocardiogram
Time frame: from pre-dose to 7+/-2 days post dose
12-lead electrocardiogram measurement
Incidence of clinically significant changes in serum biomarker levels in a standard serum chemistry panel
Time frame: from pre-dose to 7+/-2 days post dose
Changes in standard serum chemistry measures will be assessed.
Incidence of clinically significant changes in hematological biomarker levels in a standard hematology panel
Time frame: from pre-dose to 7+/-2 days post dose
Changes in standard hematology measures will be assessed.
Incidence of clinically significant changes in urine biomarker levels in a standard urinalysis panel
Time frame: from pre-dose to 7+/-2 days post dose
Changes in standard urinalysis measures will be assessed.
Number of patients exhibiting changes in standard Physical Examination results
Time frame: from pre-dose to 7+/-2 days post dose
Number of patients exhibiting changes in standard Neurological Examination results
Time frame: from pre-dose to 7+/-2 days post dose
7 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 0-48 hours post dose
Time to Cmax (Tmax)
Time frame: 0-48 hours post dose
Area under the plasma concentration vs. time curve (AUC)
Time frame: 0-48 hours post dose
Terminal rate constant
Time frame: 0-48 hours post dose
Terminal half-life (t1/2)
Time frame: 0-48 hours post dose
Apparent plasma clearance (CL/F)
Time frame: 0-48 hours post dose
Renal clearance (CLr)
Time frame: 0-48 hours post dose
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 3 Sep 2020.
- Background: PubMed 22194796Chen Q, Prior M, Dargusch R, Roberts A, Riek R, Eichmann C, Chiruta C, Akaishi T, Abe K, Maher P, Schubert D. A novel neurotrophic drug for cognitive enhancement and Alzheimer's disease. PLoS One. 2011;6(12):e27865. doi: 10.1371/journal.pone.0027865. Epub 2011 Dec 14.
- Background: PubMed 23673233Prior M, Dargusch R, Ehren JL, Chiruta C, Schubert D. The neurotrophic compound J147 reverses cognitive impairment in aged Alzheimer's disease mice. Alzheimers Res Ther. 2013 May 14;5(3):25. doi: 10.1186/alzrt179. eCollection 2013.
- Background: PubMed 26564964Currais A, Goldberg J, Farrokhi C, Chang M, Prior M, Dargusch R, Daugherty D, Armando A, Quehenberger O, Maher P, Schubert D. A comprehensive multiomics approach toward understanding the relationship between aging and dementia. Aging (Albany NY). 2015 Nov;7(11):937-55. doi: 10.18632/aging.100838.
- Background: PubMed 27149904Prior M, Goldberg J, Chiruta C, Farrokhi C, Kopynets M, Roberts AJ, Schubert D. Selecting for neurogenic potential as an alternative for Alzheimer's disease drug discovery. Alzheimers Dement. 2016 Jun;12(6):678-86. doi: 10.1016/j.jalz.2016.03.016. Epub 2016 May 2.
- Background: PubMed 29316249Goldberg J, Currais A, Prior M, Fischer W, Chiruta C, Ratliff E, Daugherty D, Dargusch R, Finley K, Esparza-Molto PB, Cuezva JM, Maher P, Petrascheck M, Schubert D. The mitochondrial ATP synthase is a shared drug target for aging and dementia. Aging Cell. 2018 Apr;17(2):e12715. doi: 10.1111/acel.12715. Epub 2018 Jan 7.
- 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.
Martin Kankam, MD, PhD, MPH principal investigator
Vince & Associates Clinical Research, 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 J147 in people with Alzheimer's Disease, run by Abrexa Pharmaceuticals, 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 6 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 3 Sep 2020. 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?
Incidence of treatment-emergent adverse events (time frame: from pre-dose to 7+/-2 days post dose). 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?
On the ClinicalTrials.gov record for NCT03838185, which also lists 5 linked publications.
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 3 Sep 2020.