Study of COR388 HCl in Healthy Subjects



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/17/2018
Start Date:December 11, 2017
End Date:March 2018
Contact:Samer Kaba, MD
Email:clinicaltrials@cortexyme.com
Phone:1-404-819-3726

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A Phase 1 Single Ascending Dose Study of COR388 HCl

The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human
trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.


Major Inclusion Criteria:

1. Males of reproductive potential must agree to use double-barrier contraceptive
measures or avoid intercourse from Day -1 through 28 days after the dose of study
drug;

2. Females of child-bearing potential must be non-lactating, have negative serum
pregnancy test results at screening visit and Day 1; agree to use double-barrier
contraceptive measures or avoid intercourse from Day -10 through 28 days after the
dose of study drug;

3. Body mass index (BMI) ≥19 to ≤32 kg/m2;

4. Good health as determined by the absence of clinically significant deviation from
normal, by medical history, physical examination, laboratory reports, and 12-lead
electrocardiogram (ECG) prior to enrollment;

5. Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for
the duration of the study;

6. Able to understand and willing to comply with all study requirements, and follow the
study medication regimen.

Major Exclusion Criteria:

1. History or current evidence of cardiac, hepatic, renal, pulmonary, endocrine,
neurologic, gastrointestinal, hematologic, oncologic, infectious, or psychiatric
disease as determined by screening history, physical examination, laboratory reports,
or 12-lead ECG;

2. Need for any concomitant medication (with the exception of hormonal contraceptives as
allowed for females of child-bearing potential);

3. Use of any prescription drug within 14 days prior to the first dose of the study (with
the exception of hormonal contraceptives for females of childbearing potential);

4. Use of any non-prescription drug and/or herbal supplements within 7 days prior to the
first dose of the study;

5. History of significant allergic reaction to any drug;

6. Participation in another investigational new drug research study within the 30 days
prior to the first dose of the study;

7. History of alcohol or drug abuse or dependence within 12 months of screening as
determined by the Investigator;

8. Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.
We found this trial at
1
site
Cincinnati, Ohio 45212
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from
Cincinnati, OH
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