Clinical trial NCT03331900: Study of COR388 HCl in Healthy Subjects
Official title: A Phase 1 Single Ascending Dose Study of COR388 HCl
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Cortexyme Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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: 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.

Primary outcomes:
measure: Area under the plasma concentration curve (AUC)
timeFrame: 72 hours
measure: Maximum observed plasma concentration (Cmax)
timeFrame: 72 hours
measure: Time of the first occurrence of the maximum observed plasma concentration (Tmax)
timeFrame: 72 hours
Secondary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: 72 Hours
measure: Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin).
timeFrame: 72 hours
measure: Changes in hematology lab measures (RBC, Hgb, Hct).
timeFrame: 72 hours
measure: Changes in urinalysis lab parameters (pH, specific gravity, glucose).
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
Study officials:
References: