Healthy Subjects
Conditions
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.
Interventions
DRUGCOR388
Administered as oral capsule
DRUGPlacebo
Administered as oral capsule
Sponsors
Cortexyme Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | 72 hours | Analysis of Cmax |
| Area under the plasma concentration curve (AUC) | 72 hours | Analysis of AUC |
| Time of the first occurrence of the maximum observed plasma concentration (Tmax) | 72 hours | Analysis of Tmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events | 72 Hours | Assessment of the incidence and severity of treatment-emergent adverse events. |
| Changes in urinalysis lab parameters (pH, specific gravity, glucose). | 72 hours | Assessment of changes in urinalysis parameters. |
| Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin). | 72 hours | Assessment of changes in serum chemistry measures. |
| Changes in hematology lab measures (RBC, Hgb, Hct). | 72 hours | Assessment of changes in hematology measures. |
Countries
United States
Outcome results
None listed