Healthy VolunteersPhase 1NCT05344989
A First-in-Human Study to Assess Single Doses of APNmAb005 in Healthy Participants
A Phase 1 study testing APNmAb005 in people with Healthy Volunteers and Tauopathies, run by APRINOIA Therapeutics, LLC at 1 site in United States.
Trial summary
This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5 dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per cohort. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Tauopathies, Alzheimer Disease
- What is being tested?
- APNmAb005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2022to Jul 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) of 18.5 to 32 kg/m² inclusive, at screening.
- Female subjects of childbearing potential must use an acceptable method of birth control from screening until at least 90 days after study drug dosing; OR be surgically sterile; OR be postmenopausal. All female subjects must have a negative pregnancy test at screening and before the first dose of the study drug. Female subjects must also agree to refrain from egg donation during the study and for at least 90 days after study drug dosing.
- Male subjects must agree to use a condom when sexually active with a female partner of childbearing potential during the study and for at least 90 days after study drug dosing (or be surgically sterile); OR agree to practice abstinence during the study and for at least 90 days after study drug dosing. Male subjects must also agree to refrain from sperm donation during the study and for at least 90 days after study drug dosing.
- Agree to comply with all protocol requirements.
- Provide written informed consent.
Who cannot join
- Unable or unwilling to undergo venipuncture or tolerate venous access, or is unable or unwilling to undergo lumbar puncture.
- Has any significant acute or chronic medical illness that would impact the subject's ability to complete all study requirements or impact assessment of study data; or subject as had a clinically significant illness within 30 days prior to study drug dosing.
- Any medical condition or documented history that is a contraindication to lumbar puncture (e.g. bleeding disorder, spinal deformity).
- Positive COVID-19 molecular diagnostic test result at screening or prior to study drug dosing; or subject has known or suspected consequence from prior COVID-19 infection.
- History of cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or oncogenic (with the exception of resected skin basal cell carcinoma) disease within 5 years prior to screening).
- NOTE: Subjects with treated stable psychiatric conditions (e.g. anxiety, depression) are not allowed.
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- Clinically significant neurological or psychiatric disorder.
- Major surgery, as determined by investigator, within 4 weeks prior to study drug dosing.
- Systolic blood pressure >140 mm Hg and/or diastolic blood pressure >90 mm Hg.
- Received any vaccine or used any prescription or over-the-counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days prior to study drug dosing.
- Consumed caffeine- or xanthine-containing products within 48 hours prior to study drug dosing.
- Subject is a smoker or has regularly used nicotine or nicotine-containing products (e.g. snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months prior to study drug dosing.
- Subject is involved in vigorous or strenuous physical activity or contact sports within 24 hours prior to study drug dosing.
- Subject has donated blood or blood products >450 mL within 3 months prior to study drug dosing.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Research, LLC., 2600 Redondo Ave.
Long Beach, California, 90806
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APNmAb005 in Healthy Subjects
This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5 dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per cohort. the starting dose of APNmAb005 is 5 mg/kg and the anticipated doses for subsequent cohorts are 10, 25, 50 and 70 mg/kg. A Safety Review Team (SRT) will review data on an ongoing basis throughout the study and before progression to the next dose level cohort.
Subjects will receive a single dose of either APNmAb005 or placebo administered as a single IV infusion on Day 1 of the study and will remain in the study center until Day 3 (48 hours after dosing). They will return to the study center for 7 outpatient visits. The duration of the study, excluding screening, is approximately 71 days.
- Conditions
- Healthy Volunteers, Tauopathies, Alzheimer Disease
- Being tested
- APNmAb005, Placebo
- Keywords
- Healthy Volunteers, Alzheimer's Disease, Alzheimer Disease, AD, Tauopathies, Tau
- Medical subject headings
- Tauopathies, Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APNmAb005Drug
Administered by IV infusion
PlaceboDrug
Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| APNmAb005 (5mg/kg) vs Placebo | Active comparator | Single Ascending Dose (SAD) Receives: Drug: APNmAb005; Drug: Placebo |
| APNmAb005 (10 mg/kg) vs Placebo | Active comparator | Single Ascending Dose (SAD) Receives: Drug: APNmAb005; Drug: Placebo |
| APNmAb005 (25 mg/kg) vs Placebo | Active comparator | Single Ascending Dose (SAD) Receives: Drug: APNmAb005; Drug: Placebo |
| APNmAb005 (50 mg/kg) vs Placebo | Active comparator | Single Ascending Dose (SAD) Receives: Drug: APNmAb005; Drug: Placebo |
| APNmAb005 (70 mg/kg) vs Placebo | Active comparator | Single Ascending Dose (SAD) Receives: Drug: APNmAb005; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Adverse Events (AEs)
Defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.
Measured: Day 70
Number of subjects with Treatment-emergent AEs (TEAEs)
Defined as any event not present before exposure to study drug or any event already present that worsens in intensity or frequency after exposure. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.
Measured: Day 70
Number of subjects with Serious Adverse Events (SAEs)
Defined as any AE for which there is a reasonable possibility that the study drug caused the AE. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.
Measured: Day 70
Number of subjects with AEs resulting in Study Discontinuation
Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.
Measured: Day 70
Number of participants with Vital Sign Abnormalities
Measured by systolic and diastolic blood pressures, pulse rate, respiratory rate and body temperature.
Measured: Day 70
Number of participants with Electrocardiogram (ECG) Abnormalities
Measured by 12-lead ECG
Measured: Day 70
Number of participants with Clinical Laboratory Abnormalities
Measured by hematology, coagulation, serum chemistry and urinalysis.
Measured: Day 70
Secondary outcomes (30)
AUC0-t of APNmAb005 in plasma
Area under the curve from time zero to last quantifiable concentration of APNmAb005. Measured by blood sample analysis.
Measured: Thru Day 70
AUC0-t of APNmAb005 in CSF
Area under the curve from time zero to last quantifiable concentration of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis.
Measured: Thru Day 14
Cmax of APNmAb005 in blood
Maximum observed plasma concentration of APNmAb005. Measured by blood sample analysis
Measured: Thru Day 70
Cmax of APNmAb005 in CSF
Maximum observed plasma concentration of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis.
Measured: Thru Day 14
Tmax of APNmAb005 in blood
Time to maximum observed plasma concentration following APNmAb005 administration. Measured by blood sample analysis
Measured: Thru Day 70
Tmax of APNmAb005 in CSF
Time to maximum observed plasma concentration following APNmAb005 administration. Measured by cerebrospinal fluid (CSF) sample analysis.
Measured: Thru Day 14
t1/2 of APNmAb005 in plasma
Terminal phase half-life of APNmAb005. Measured by blood sample analysis
Measured: Thru Day 70
t1/2 of APNmAb005 in CSF
Terminal phase half-life of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis
Measured: Thru Day 14
CL of APNmAb005 in blood.
Total body clearance of APNmAb005 from plasma. Measured by blood sample analysis
Measured: Thru Day 70
CL of APNmAb005 in CSF
Total body clearance of APNmAb005 from plasma. Measured by cerebrospinal fluid (CSF) sample analysis
Measured: Thru Day 14
Vd of APNmAb005 in plasma
Volume of distribution of APNmAb005. Measured by blood sample analysis
Measured: Thru Day 70
Vd of APNmAb005 in CSF
Volume of distribution of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis
Measured: Thru Day 14
Number of participants with ADA formation against APNmAb005
Anti-drug antibody (ADA) presence measured by blood sample analysis
Measured: Thru Day 70
Number of participants with no ADA formation against APNmAb005
Anti-drug antibody (ADA) presence measured by blood sample analysis
Measured: Thru Day 70
Mean Total tau concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Measured: Thru Day 70
Mean change in Total tau concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Measured: Baseline and Day 70
Mean Total tau concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Measured: Thru Day 14
Mean change in Total tau concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Measured: Baseline and Day 14
Mean p-tau 181 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Measured: Thru Day 70
Mean change in p-tau 181 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Measured: Baseline and Day 70
Mean p-tau 181 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Measured: Thru Day 14
Mean change in p-tau 181 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Measured: Baseline and Day 14
Mean p-tau 217 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Measured: Thru Day 70
Mean change in p-tau 217 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Measured: Baseline and Day 70
Mean p-tau 217 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Measured: Thru Day 14
Mean change in p-tau 217 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Measured: Baseline and Day 14
Mean p-tau 231 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Measured: Thru Day 70
Mean change in p-tau 231 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Measured: Baseline and Day 70
Mean p-tau 231 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Measured: Thru Day 14
Mean change in p-tau 231 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Measured: Baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start6 May 2022
- Primary completionMar 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- APRINOIA Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Reynolds, DO, Principal investigator, Collaborative Neuroscience Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344989
- Sponsor's protocol ID
- APNmAb005-101
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APNmAb005 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05344989
- Acronym / sponsor ID
- APNmAb005-101
- Conditions
- Healthy Volunteers, Tauopathies, Alzheimer Disease
- Keywords
- Healthy Volunteers, Alzheimer's Disease, Alzheimer Disease, AD, Tauopathies, Tau
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- APRINOIA Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 May 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 25 Apr 2022 (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 Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5 dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per cohort. the starting dose of APNmAb005 is 5 mg/kg and the anticipated doses for subsequent cohorts are 10, 25, 50 and 70 mg/kg. A Safety Review Team (SRT) will review data on an ongoing basis throughout the study and before progression to the next dose level cohort.
Subjects will receive a single dose of either APNmAb005 or placebo administered as a single IV infusion on Day 1 of the study and will remain in the study center until Day 3 (48 hours after dosing). They will return to the study center for 7 outpatient visits. The duration of the study, excluding screening, is approximately 71 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| APNmAb005 (5mg/kg) vs Placebo | Active comparator | Drug: APNmAb005, Drug: PlaceboSingle Ascending Dose (SAD) |
| APNmAb005 (10 mg/kg) vs Placebo | Active comparator | Drug: APNmAb005, Drug: PlaceboSingle Ascending Dose (SAD) |
| APNmAb005 (25 mg/kg) vs Placebo | Active comparator | Drug: APNmAb005, Drug: PlaceboSingle Ascending Dose (SAD) |
| APNmAb005 (50 mg/kg) vs Placebo | Active comparator | Drug: APNmAb005, Drug: PlaceboSingle Ascending Dose (SAD) |
| APNmAb005 (70 mg/kg) vs Placebo | Active comparator | Drug: APNmAb005, Drug: PlaceboSingle Ascending Dose (SAD) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) of 18.5 to 32 kg/m² inclusive, at screening.
- Female subjects of childbearing potential must use an acceptable method of birth control from screening until at least 90 days after study drug dosing; OR be surgically sterile; OR be postmenopausal. All female subjects must have a negative pregnancy test at screening and before the first dose of the study drug. Female subjects must also agree to refrain from egg donation during the study and for at least 90 days after study drug dosing.
- Male subjects must agree to use a condom when sexually active with a female partner of childbearing potential during the study and for at least 90 days after study drug dosing (or be surgically sterile); OR agree to practice abstinence during the study and for at least 90 days after study drug dosing. Male subjects must also agree to refrain from sperm donation during the study and for at least 90 days after study drug dosing.
- Agree to comply with all protocol requirements.
- Provide written informed consent.
Key exclusion criteria (15 listed)
- Unable or unwilling to undergo venipuncture or tolerate venous access, or is unable or unwilling to undergo lumbar puncture.
- Has any significant acute or chronic medical illness that would impact the subject's ability to complete all study requirements or impact assessment of study data; or subject as had a clinically significant illness within 30 days prior to study drug dosing.
- Any medical condition or documented history that is a contraindication to lumbar puncture (e.g. bleeding disorder, spinal deformity).
- Positive COVID-19 molecular diagnostic test result at screening or prior to study drug dosing; or subject has known or suspected consequence from prior COVID-19 infection.
- History of cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or oncogenic (with the exception of resected skin basal cell carcinoma) disease within 5 years prior to screening).
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 |
|---|---|---|
| APNmAb005Administered by IV infusion | Drug | APNmAb005 (10 mg/kg) vs Placebo, APNmAb005 (25 mg/kg) vs Placebo, APNmAb005 (50 mg/kg) vs Placebo, APNmAb005 (5mg/kg) vs Placebo, APNmAb005 (70 mg/kg) vs Placebo |
| PlaceboAdministered by IV infusion | Drug | APNmAb005 (10 mg/kg) vs Placebo, APNmAb005 (25 mg/kg) vs Placebo, APNmAb005 (50 mg/kg) vs Placebo, APNmAb005 (5mg/kg) vs Placebo, APNmAb005 (70 mg/kg) vs Placebo |
Primary outcome
Number of subjects with Adverse Events (AEs)
Time frame: Day 70
Defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.
Number of subjects with Treatment-emergent AEs (TEAEs)
Time frame: Day 70
Defined as any event not present before exposure to study drug or any event already present that worsens in intensity or frequency after exposure. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.
Number of subjects with Serious Adverse Events (SAEs)
Time frame: Day 70
Defined as any AE for which there is a reasonable possibility that the study drug caused the AE. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.
Number of subjects with AEs resulting in Study Discontinuation
Time frame: Day 70
Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.
Number of participants with Vital Sign Abnormalities
Time frame: Day 70
Measured by systolic and diastolic blood pressures, pulse rate, respiratory rate and body temperature.
Number of participants with Electrocardiogram (ECG) Abnormalities
Time frame: Day 70
Measured by 12-lead ECG
Number of participants with Clinical Laboratory Abnormalities
Time frame: Day 70
Measured by hematology, coagulation, serum chemistry and urinalysis.
30 secondary outcomes
AUC0-t of APNmAb005 in plasma
Time frame: Thru Day 70
AUC0-t of APNmAb005 in CSF
Time frame: Thru Day 14
Cmax of APNmAb005 in blood
Time frame: Thru Day 70
Cmax of APNmAb005 in CSF
Time frame: Thru Day 14
Tmax of APNmAb005 in blood
Time frame: Thru Day 70
Tmax of APNmAb005 in CSF
Time frame: Thru Day 14
t1/2 of APNmAb005 in plasma
Time frame: Thru Day 70
t1/2 of APNmAb005 in CSF
Time frame: Thru Day 14
CL of APNmAb005 in blood.
Time frame: Thru Day 70
CL of APNmAb005 in CSF
Time frame: Thru Day 14
Vd of APNmAb005 in plasma
Time frame: Thru Day 70
Vd of APNmAb005 in CSF
Time frame: Thru Day 14
Number of participants with ADA formation against APNmAb005
Time frame: Thru Day 70
Number of participants with no ADA formation against APNmAb005
Time frame: Thru Day 70
Mean Total tau concentration in plasma
Time frame: Thru Day 70
Mean change in Total tau concentration in plasma
Time frame: Baseline and Day 70
Mean Total tau concentration in CSF
Time frame: Thru Day 14
Mean change in Total tau concentration in CSF
Time frame: Baseline and Day 14
Mean p-tau 181 concentration in plasma
Time frame: Thru Day 70
Mean change in p-tau 181 concentration in plasma
Time frame: Baseline and Day 70
Mean p-tau 181 concentration in CSF
Time frame: Thru Day 14
Mean change in p-tau 181 concentration in CSF
Time frame: Baseline and Day 14
Mean p-tau 217 concentration in plasma
Time frame: Thru Day 70
Mean change in p-tau 217 concentration in plasma
Time frame: Baseline and Day 70
Mean p-tau 217 concentration in CSF
Time frame: Thru Day 14
Mean change in p-tau 217 concentration in CSF
Time frame: Baseline and Day 14
Mean p-tau 231 concentration in plasma
Time frame: Thru Day 70
Mean change in p-tau 231 concentration in plasma
Time frame: Baseline and Day 70
Mean p-tau 231 concentration in CSF
Time frame: Thru Day 14
Mean change in p-tau 231 concentration in CSF
Time frame: Baseline and Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Steven Reynolds, DO principal investigator
Collaborative Neuroscience Research, LLC
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 APNmAb005 in people with Healthy Volunteers and Tauopathies, run by APRINOIA Therapeutics, LLC 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 15 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Adverse Events (AEs) (time frame: Day 70). 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 15 Jun 2023.