StrokePhase 1NCT03804476
Phase 1 Study to Assess AER-271
A Phase 1 study testing AER-271 in people with Stroke and Stroke, Acute, run by Aeromics, Inc. at 1 site in United States.
Trial summary
The objective of this Phase 1 trial is to assess the safety, tolerability and pharmacokinetics of AER-271 in health subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Stroke, Acute, Stroke, Ischemic
- What is being tested?
- AER-271
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2018to 28 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, of any ethnic origin, between 18 and 45 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspected Gilbert's syndrome, as determined by total bilirubin and indirect bilirubin] is acceptable) at Screening and/or Check-in, as assessed by the Investigator.
- Male subjects must be surgically sterile for at least 90 days or, for males capable of fathering children who are sexually active with female partners of childbearing potential, will use the required contraception methods, and will refrain from donating sperm from the time of the first dose until 90 days after the final dosing occasion.
- Female subjects must be:
- postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause) with a screening serum follicle-stimulating hormone (FSH) level > 40 mIU/mL, or
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- permanently sterile following hysterectomy, Essure procedure, bilateral salpingectomy, bilateral oophorectomy, or confirmed tubal occlusion (not tubal ligation).
- Venous access sufficient for IV infusions.
- Able to comprehend and willing to sign an Informed Consent Form (ICF) and to abide by the study restrictions.
Who cannot join
- Female subjects who are pregnant or lactating.
- Have any clinically significant abnormal physical examination finding at Check-in.
- Have any clinically significant medical history, as determined by the Investigator.
- History of seizure disorder, even if currently not receiving anticonvulsant medications.
- Part B only: Have acute suicidality, as evidenced by answering "yes" for Question 4 or Question 5 on the C-SSRS, indicating active suicidal ideation with any intent to act at Screening and Check-in.
- Part B only: Have a history of suicidal behavior such that a determination of "yes" is made on the Suicidal Behavior section of the C-SSRS for "Actual Attempt," "Interrupted Attempt," "Aborted Attempt," or "Preparatory Acts or Behavior" at Screening and Check-in.
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- History or clinical manifestations of clinically significant metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary, cardiovascular, gastrointestinal (cholecystectomy and appendectomy are acceptable), neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders (a history of mild depression, currently not receiving therapy, is acceptable), as determined by the Investigator.
- Have any clinically significant allergic condition (excluding non-active hay fever), as determined by the Investigator.
- Have a significant history of drug allergy, as determined by the Investigator.
- Have a clinically significant abnormality in oral temperature, respiratory rate, or supine pulse rate or blood pressure at Screening and prior to first dose that, in the opinion of the Investigator, increases the risk of participating in the study.
- Electrocardiogram findings that meet any of the following criteria at Screening or Day-1 (if out of range, ECG may be repeated twice, and the triplicate average will be used):
- QTcF >450 msec confirmed by repeat measurement,
- QRS duration > 120 msec,
- PR interval >220 msec,
- findings which would make QTc measurements difficult or QTc data uninterpretable.
- History of additional risk factors for torsades de pointe (eg, heart failure, hypokalemia, family history of long QT syndrome).
- Have clinically significant arrhythmias or sinus pauses identified in the continuous 12-lead ECG monitoring on Day -1, as determined by the Investigator.
- Have any clinically significant abnormal laboratory safety findings at Screening and Check-in, as determined by the Investigator or designee (one repeat assessment is acceptable). Note: Liver function tests (eg, AST, ALT, total bilirubin, GGT) and inflammatory response markers (eg, white blood cell and absolute neutrophil and monocyte counts) must be within the normal range at Screening (one repeat assessment is acceptable) (after Screening this will be as determined by the Investigator).
- A positive hepatitis virus test (hepatitis B surface antigen or hepatitis C virus antibody) or a positive human immunodeficiency virus antibody test (or p24 antigen) at Screening.
- Have had a clinically significant illness within 4 weeks of first dose, as determined by the Investigator (or designee).
- Alcohol consumption of > 21 units per week for males and > 14 units per week for females. Note: One unit of alcohol equals 12 oz (360 mL) beer, 1.5 oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Significant history of alcoholism or drug/chemical abuse, as determined by the Investigator.
- An active smoker or user of other forms of tobacco. Former smokers or tobacco users must have refrained from smoking or using other forms of tobacco for at least 6 months prior to dosing on Day 1 until the Follow-up visit.
- Have donated blood from 90 days prior to Screening, platelets from 42 days prior to Screening, or plasma from 7 days prior to Screening until 56 days after the Follow-up visit.
- Have received another investigational drug within 30 days prior to randomization.
- Have received known inhibitors or inducers of CYP1A2 or any medications or herbal remedies, including St. John's Wort, known to chronically alter drug absorption or elimination processes within 30 days prior to first dose administration, until the Follow-up visit, unless in the opinion of the Investigator (or designee), Medical Monitor, and/or Aeromics, the medication will not interfere with the study procedures or compromise safety.
- Use of any prescription medications/products within 14 days prior to randomization, or use of nonprescription, over-the-counter medication/products, including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations, within 7daysprior to randomization until the Follow-up visit. Exceptions may be made by the Medical Monitor, Investigator (or designee), and/or Aeromics on a case-by-case basis. Intermittent use of acetaminophen at moderate daily doses (eg, ≤ 1g per day for ≤2 consecutive days) may be allowed at the discretion of the Investigator.
- Positive urine drug screen at Screening (not including cotinine or alcohol) or Check-in (including cotinine and alcohol), confirmed by repeat.
- Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges within 7 days prior to Check-in until the Follow-up visit.
- Subjects unwilling to refrain from strenuous exercise from 7 days before Check- in until the Follow-up visit.
- Consumption of alcohol-containing foods and beverages within 72 hours prior to Check-in until the Follow-up visit.
- Consumption of caffeine-containing foods and beverages within 72 hours prior to Check-in until discharge on Day 3 for Part A or on Day 12 for Part B.
- Have previously taken part in or withdrawn from this study.
- Subjects who, in the opinion of the Investigator, should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Sequential-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of AER-271 in Healthy Subjects
The objective of this Phase 1 trial is to assess the safety, tolerability and pharmacokinetics of AER-271 in health subjects.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, sequential-group study to assess the safety, tolerability and pharmacokinetics of single ascending dose and multiple ascending doses of intravenously (IV) administered AER-271 in healthy human subjects. AER-271 is an Aquaporin-4 inhibitor designed to prevent brain swelling in severe ischemic stroke. The study will be conducted in 2 parts: Part A is a single ascending dose, sequential group study. The subsequent Part B is a multiple ascending dose, sequential group study. Both Parts A and B will follow an adaptive design including the use of Sentinel Dosing.
The primary objectives of this study are to assess the safety and tolerability of single and multiple IV doses and continuous infusion of AER-271 in healthy subjects. Secondary objectives include: determining the pharmacokinetics of AER-271 and AER-270 following administration of AER-271, determining the dose proportionality for AER-270 and 271, and comparing the effects of continuous infusion versus multiple bolus doses on AER-271 exposure and adverse events. An additional exploratory objective of this study is to evaluate the effects of AER-271 on electrocardiogram parameters including QT interval corrected for heart rate. Data from this trial will also be used to develop a protocol for a subsequent Phase 2 clinical trial in stroke patients.
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic
- Being tested
- AER-271, Placebo
- Keywords
- stroke, acute ischemic stroke, cerebral edema
- Medical subject headings
- Stroke, Ischemic Stroke, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AER-271Drug
AER-271, the test article for this study.
PlaceboDrug
Placebo control for this study.
| Study group | Role | What they receive |
|---|---|---|
| AER-271 | Experimental | The experimental drug AER-271 will be administered in this Arm. In Part A single ascending doses will be administered by IV bolus infusion of AER-271 formulated in phosphate buffered normal saline over a 30-min period. In Part B multiple ascending doses of AER-271 will be administered by IV 30-min bolus infusion BID for 72 hours. AER-271 will also be administered as an initial bolus dose over 30-min then continuous infusion over 72 hours. Receives: Drug: AER-271 |
| Placebo | Placebo comparator | A placebo control will be administered in this Arm. In Part A phosphate buffered normal saline will be administered over a 30-min period. In Part B multiple doses of phosphate buffered normal saline will be administered by IV 30-min bolus infusion BID for 72 hours. This placebo will also be administered as an initial bolus dose over 30-min then continuous infusion over 72 hours. In both Parts, the volume of placebo administered will be the same as the Experimental Arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that experience adverse events
Observation for signs and symptoms of adverse events
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients that experience serious adverse events
Observation for signs and symptoms of serious adverse events
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in ALT levels
Patients with serum Alanine Aminotransferase exceeding or below normal values will be reported with the concentration in IU/L
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in AST levels
Patients with serum Aspartate Aminotransferase exceeding or below normal values will be reported with the concentration in IU/L
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in GGT levels
Patients with serum Gamma-Glutamyl Transferase exceeding or below normal values will be reported with the concentration in IU/L
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in WBC
Patients with White Blood Cell Count exceeding or below normal values will be reported in count/uL
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in RBC
Patients with Red Blood Cell Count exceeding or below normal values will be reported in count/uL
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Albumin levels
Patients with serum Albumin exceeding or below normal values will be reported with the concentration in g/dL
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Bilirubin levels
Patients with Bilirubin exceeding or below normal values will be reported with the concentration in mg/dL
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Platelet counts
Patients with Platelet counts exceeding or below normal values will be reported as count/uL
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Hematocrit
Patients with Hematocrit exceeding or below normal values will be reported as a %
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Creatinine
Patients with serum Creatinine exceeding or below normal values will be reported with the concentration in mg/dL
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Alkaline Phosphatase levels
Patients with serum Alkaline Phosphatase exceeding or below normal values will be reported with the concentration in IU/L
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Cholesterol levels
Patients with Cholesterol exceeding or below normal values will be reported with the concentration in mg/dL
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Respiratory Rate
Patients with changes in Respiratory Rate will be reported in count/min
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Pulse Rate
Patients with changes in Pulse Rate will be reported in count/min
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Oral Temperature
Patients with changes in Oral Temperature above normal will be reported in degrees Celcius (C)
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients with significant changes in Blood Pressure
Patients with changes in Supine Blood Pressure exceeding or below normal values will be reported in mmHg systolic over diastolic
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients exhibiting changes in Physical Examination
Number of patients exhibiting any changes in the physical examination during this period will be reported.
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Secondary outcomes (8)
Pharmacokinetic parameter: Mean Cmax +/- standard deviation
Maximum concentration of AER-271 and AER-270 derived from plasma concentration-time profile (ng/mL)
Measured: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Pharmacokinetic parameter: Mean AUC +/- standard deviation
Area Under the Curve for AER-271 and AER-270 derived from plasma concentration-time profile (hr*ng/mL)
Measured: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Pharmacokinetic parameter: Mean CL +/- standard deviation
Clearance of AER-271 derived from plasma concentration-time profile (mL/hr/kg)
Measured: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Pharmacokinetic parameter: Mean T1/2 +/- standard deviation
Half-life of AER-271 and AER-270 derived from plasma concentration-time profile (hr)
Measured: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Pharmacokinetic parameter: Mean Vss +/- standard deviation
Steady state volume of distribution of AER-271 derived from plasma concentration-time profile (mL/kg)
Measured: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Changes in ECG Parameters: Mean QTcF +/- standard deviation
QT Interval Corrected by Fridericia's Formula (msec)
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Changes in ECG Parameters: Mean QRS +/- standard deviation
QRS Duration (msec)
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Changes in ECG Parameters: Mean PR +/- standard deviation
PR Interval (msec)
Measured: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start26 Jun 2018
- Primary completion18 Jul 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- A double-blind, randomized, placebo-controlled, sequential-group, single and multiple intravenous dose escalation study conducted in 2 parts. Both Parts A and B will comprise an adaptive design. Part A sentinel dosing will randomize the first 2 subjects 1:1 AER-271:placebo. The remaining 6 subjects in a cohort will be randomized 5:1 AER-271:placebo and administered drug after the Safety Monitoring Board (SMB) has reviewed the first 24 hours of safety data for the first 2 subjects. Part B sentinel dosing will randomize the first 4 subjects 2:2 AER-271:placebo. The remaining 6 subjects in a cohort will be randomized 4:2 AER-271:placebo and administered study drug after the SMB has reviewed the first 24 hours of safety data for the first 4 subjects. Part A will have 6 cohorts and Part B will have 3. Additional cohorts may be enrolled to explore additional dose levels. The planned study design may be modified in accordance with the adaptive features of the clinical study protocol.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeromics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Paul R McGuirk, PhD, Principal investigator, Aeromics, Inc.Alex King, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804476
- Sponsor's protocol ID
- 174273
- Status last verified
- Jul 2020
- First submitted
- 9 Jan 2019
- Last updated
- 9 Jul 2020
- 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 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Sequential-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of AER-271 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03804476
- Acronym / sponsor ID
- 174273
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic
- Keywords
- stroke, acute ischemic stroke, cerebral edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aeromics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 15 Jan 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.
The objective of this Phase 1 trial is to assess the safety, tolerability and pharmacokinetics of AER-271 in health subjects.
Detailed description
This is a double-blind, randomized, placebo-controlled, sequential-group study to assess the safety, tolerability and pharmacokinetics of single ascending dose and multiple ascending doses of intravenously (IV) administered AER-271 in healthy human subjects. AER-271 is an Aquaporin-4 inhibitor designed to prevent brain swelling in severe ischemic stroke. The study will be conducted in 2 parts: Part A is a single ascending dose, sequential group study. The subsequent Part B is a multiple ascending dose, sequential group study. Both Parts A and B will follow an adaptive design including the use of Sentinel Dosing.
The primary objectives of this study are to assess the safety and tolerability of single and multiple IV doses and continuous infusion of AER-271 in healthy subjects. Secondary objectives include: determining the pharmacokinetics of AER-271 and AER-270 following administration of AER-271, determining the dose proportionality for AER-270 and 271, and comparing the effects of continuous infusion versus multiple bolus doses on AER-271 exposure and adverse events. An additional exploratory objective of this study is to evaluate the effects of AER-271 on electrocardiogram parameters including QT interval corrected for heart rate. Data from this trial will also be used to develop a protocol for a subsequent Phase 2 clinical trial in stroke patients.
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
- A double-blind, randomized, placebo-controlled, sequential-group, single and multiple intravenous dose escalation study conducted in 2 parts. Both Parts A and B will comprise an adaptive design. Part A sentinel dosing will randomize the first 2 subjects 1:1 AER-271:placebo. The remaining 6 subjects in a cohort will be randomized 5:1 AER-271:placebo and administered drug after the Safety Monitoring Board (SMB) has reviewed the first 24 hours of safety data for the first 2 subjects. Part B sentinel dosing will randomize the first 4 subjects 2:2 AER-271:placebo. The remaining 6 subjects in a cohort will be randomized 4:2 AER-271:placebo and administered study drug after the SMB has reviewed the first 24 hours of safety data for the first 4 subjects. Part A will have 6 cohorts and Part B will have 3. Additional cohorts may be enrolled to explore additional dose levels. The planned study design may be modified in accordance with the adaptive features of the clinical study protocol.
| Arm | Type | Receives |
|---|---|---|
| AER-271 | Experimental | Drug: AER-271The experimental drug AER-271 will be administered in this Arm. In Part A single ascending doses will be administered by IV bolus infusion of AER-271 formulated in phosphate buffered normal saline over a 30-min period. In Part B multiple ascending doses of AER-271 will be administered by IV 30-min bolus infusion BID for 72 hours. AER-271 will also be administered as an initial bolus dose over 30-min then continuous infusion over 72 hours. |
| Placebo | Placebo comparator | Drug: PlaceboA placebo control will be administered in this Arm. In Part A phosphate buffered normal saline will be administered over a 30-min period. In Part B multiple doses of phosphate buffered normal saline will be administered by IV 30-min bolus infusion BID for 72 hours. This placebo will also be administered as an initial bolus dose over 30-min then continuous infusion over 72 hours. In both Parts, the volume of placebo administered will be the same as the Experimental Arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males or females, of any ethnic origin, between 18 and 45 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspected Gilbert's syndrome, as determined by total bilirubin and indirect bilirubin] is acceptable) at Screening and/or Check-in, as assessed by the Investigator.
- Male subjects must be surgically sterile for at least 90 days or, for males capable of fathering children who are sexually active with female partners of childbearing potential, will use the required contraception methods, and will refrain from donating sperm from the time of the first dose until 90 days after the final dosing occasion.
- Female subjects must be:
Key exclusion criteria (34 listed)
- Female subjects who are pregnant or lactating.
- Have any clinically significant abnormal physical examination finding at Check-in.
- Have any clinically significant medical history, as determined by the Investigator.
- History of seizure disorder, even if currently not receiving anticonvulsant medications.
- Part B only: Have acute suicidality, as evidenced by answering "yes" for Question 4 or Question 5 on the C-SSRS, indicating active suicidal ideation with any intent to act at Screening and Check-in.
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 |
|---|---|---|
| AER-271AER-271, the test article for this study. | Drug | AER-271 |
| PlaceboPlacebo control for this study. | Drug | Placebo |
Primary outcome
Number of patients that experience adverse events
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Observation for signs and symptoms of adverse events
Number of patients that experience serious adverse events
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Observation for signs and symptoms of serious adverse events
Number of patients with significant changes in ALT levels
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with serum Alanine Aminotransferase exceeding or below normal values will be reported with the concentration in IU/L
Number of patients with significant changes in AST levels
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with serum Aspartate Aminotransferase exceeding or below normal values will be reported with the concentration in IU/L
Number of patients with significant changes in GGT levels
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with serum Gamma-Glutamyl Transferase exceeding or below normal values will be reported with the concentration in IU/L
Number of patients with significant changes in WBC
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with White Blood Cell Count exceeding or below normal values will be reported in count/uL
Number of patients with significant changes in RBC
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with Red Blood Cell Count exceeding or below normal values will be reported in count/uL
Number of patients with significant changes in Albumin levels
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with serum Albumin exceeding or below normal values will be reported with the concentration in g/dL
Number of patients with significant changes in Bilirubin levels
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with Bilirubin exceeding or below normal values will be reported with the concentration in mg/dL
Number of patients with significant changes in Platelet counts
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with Platelet counts exceeding or below normal values will be reported as count/uL
Number of patients with significant changes in Hematocrit
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with Hematocrit exceeding or below normal values will be reported as a %
Number of patients with significant changes in Creatinine
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with serum Creatinine exceeding or below normal values will be reported with the concentration in mg/dL
Number of patients with significant changes in Alkaline Phosphatase levels
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with serum Alkaline Phosphatase exceeding or below normal values will be reported with the concentration in IU/L
Number of patients with significant changes in Cholesterol levels
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with Cholesterol exceeding or below normal values will be reported with the concentration in mg/dL
Number of patients with significant changes in Respiratory Rate
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with changes in Respiratory Rate will be reported in count/min
Number of patients with significant changes in Pulse Rate
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with changes in Pulse Rate will be reported in count/min
Number of patients with significant changes in Oral Temperature
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with changes in Oral Temperature above normal will be reported in degrees Celcius (C)
Number of patients with significant changes in Blood Pressure
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Patients with changes in Supine Blood Pressure exceeding or below normal values will be reported in mmHg systolic over diastolic
Number of patients exhibiting changes in Physical Examination
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Number of patients exhibiting any changes in the physical examination during this period will be reported.
8 secondary outcomes
Pharmacokinetic parameter: Mean Cmax +/- standard deviation
Time frame: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Pharmacokinetic parameter: Mean AUC +/- standard deviation
Time frame: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Pharmacokinetic parameter: Mean CL +/- standard deviation
Time frame: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Pharmacokinetic parameter: Mean T1/2 +/- standard deviation
Time frame: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Pharmacokinetic parameter: Mean Vss +/- standard deviation
Time frame: This pharmacokinetic parameter will be assessed at the end of each of 6 cohorts in the SAD study (within 1-2 weeks of final blood sample collection) and 3 cohorts in the MAD study (within 1-2 weeks of final blood sample collection).
Changes in ECG Parameters: Mean QTcF +/- standard deviation
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Changes in ECG Parameters: Mean QRS +/- standard deviation
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
Changes in ECG Parameters: Mean PR +/- standard deviation
Time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.
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 9 Jul 2020.
- 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.
Paul R McGuirk, PhD principal investigator
Aeromics, Inc.
Alex King, MD principal investigator
Covance
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 AER-271 in people with Stroke and Stroke, Acute, run by Aeromics, 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 9 inclusion and 34 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 9 Jul 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?
Number of patients that experience adverse events (time frame: Changes from baseline through day 5-7 for Part A and day 15-17 Part B.). The study lists 19 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 9 Jul 2020.