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 |
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.
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.
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