Status:
COMPLETED
Study of COR388 HCl in Healthy Subjects
Lead Sponsor:
Cortexyme Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Major
- 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;
- 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;
- Body mass index (BMI) ≥19 to ≤32 kg/m2;
- 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;
- Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study;
- Able to understand and willing to comply with all study requirements, and follow the study medication regimen.
- Major
Exclusion
- 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;
- Need for any concomitant medication (with the exception of hormonal contraceptives as allowed for females of child-bearing potential);
- 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);
- Use of any non-prescription drug and/or herbal supplements within 7 days prior to the first dose of the study;
- History of significant allergic reaction to any drug;
- Participation in another investigational new drug research study within the 30 days prior to the first dose of the study;
- History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator;
- Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03331900
Start Date
December 11 2017
End Date
April 2 2018
Last Update
April 18 2018
Active Locations (1)
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1
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227