Study of COR388 HCl in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Placebo; Drug: COR388

• Registration Number: NCT03331900
• Lead Sponsor: Cortexyme Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2017-12-11
• Primary Completion: 2018-02-20
• Status Verified: 2018-04
• Study Completion: 2018-04-02
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
COR388 TBD mg	COR388	-

Primary Outcome Measures

Name	Time	Method
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
Maximum observed plasma concentration (Cmax)	72 hours	Analysis of Cmax

Secondary Outcome Measures

Name	Time	Method
Changes in hematology lab measures (RBC, Hgb, Hct).	72 hours	Assessment of changes in hematology measures.
Incidence of treatment emergent adverse events	72 Hours	Assessment of the incidence and severity of treatment-emergent adverse events.
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 urinalysis lab parameters (pH, specific gravity, glucose).	72 hours	Assessment of changes in urinalysis parameters.

Trial Locations

Locations (1)

Medpace Clinical Pharmacology Unit; 🇺🇸 Cincinnati, Ohio, United States