Phase 1 Study to Assess AER-271

Completed · Phase 1 · Has a placebo group

Conditions studied: Stroke, Stroke, Acute, Stroke, Ischemic

In brief

The objective of this Phase 1 trial is to assess the safety, tolerability and pharmacokinetics of AER-271 in health subjects.

Key facts

Study ID: NCT03804476
Run by: Aeromics, Inc.
People needed: 80
Starts: 2018-06-26
Expected to finish: 2019-08-28
Last updated by the study team: 2020-07-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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
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.

You may not qualify if…

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.
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.

Where it is running

Covance Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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