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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04920903




Registration number
NCT04920903
Ethics application status
Date submitted
4/06/2021
Date registered
10/06/2021
Date last updated
10/09/2021

Titles & IDs
Public title
A Single and Multiple Ascending Dose Study of COR588
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human, Single- and Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Oral COR588 in Healthy Adult Subjects
Secondary ID [1] 0 0
COR588
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - COR588
Treatment: Drugs - Placebo

Experimental: COR588 -

Placebo Comparator: Placebo -


Treatment: Drugs: COR588
Increasing doses of COR588 will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.

Treatment: Drugs: Placebo
Placebo will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment emergent adverse events. - Assessment of the incidence and severity of treatment-emergent adverse events.
Timepoint [1] 0 0
Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Primary outcome [2] 0 0
Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin). - Assessment of changes in serum chemistry measures.
Timepoint [2] 0 0
Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Primary outcome [3] 0 0
Changes in hematology lab measures (red blood cell count [RBC], hemoglobin [Hgb], hematocrit [Hct]). - Assessment of changes in hematology measures.
Timepoint [3] 0 0
Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Primary outcome [4] 0 0
Changes in urinalysis lab parameters (pH, specific gravity, glucose). - Assessment of changes in urinalysis parameters.
Timepoint [4] 0 0
Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Secondary outcome [1] 0 0
AUC - Area under the concentration-time curve
Timepoint [1] 0 0
To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Secondary outcome [2] 0 0
Cmax - Maximum observed drug concentration during a dosing interval
Timepoint [2] 0 0
To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Secondary outcome [3] 0 0
Tmax - Time to Cmax
Timepoint [3] 0 0
To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.

Eligibility
Key inclusion criteria
- Healthy male and female subjects between 18 to 55 years of age, inclusive (at the time
of consent) for Part A;

- Body mass index between 18 and 32 kg/m2, inclusive, at screening and Day -1;

- Participants with no clinically significant abnormal screening results in the opinion
of the investigator;

- All screening laboratory parameters (chemistry, hematology, coagulation, urinalysis)
within normal limits or considered not clinically significant in the opinion of the
investigator. If necessary, in the investigator's opinion, screening labs may be
repeated once to confirm the results if error is suspected.

- Women of childbearing potential (WOCBP) must have a negative blood or urine pregnancy
test within 24 hours prior to the start of investigational product and must not be
breastfeeding, lactating or planning pregnancy during the study period. WOCBP must
agree to use an acceptable form of contraception during the treatment period and for
at least 30 days after the last dose of investigational product.

- A male subject with a female partner of childbearing potential is eligible to
participate if he agrees to use acceptable contraception during the treatment period
and for at least 90 days after the last dose of study treatment and refrains from
donating sperm during this period;

- Agree to comply with study-specified diet and consume the high-fat breakfast in its
entirety (food effect cohort) while confined in the study site;

- Provide signed informed consent prior to any study procedures commencing, understand
and comply with the requirements of the study, and be able to communicate with the
investigator.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Presence of significant neurological, cardiovascular, hematological, psychiatric,
hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease;

- History or presence of malignancy within the past 2 years prior to Day -1 with the
exception of adequately treated basal cell or squamous cell carcinoma of the skin;

- History of conditions (e.g., chronic diarrhea or prior abdominal surgery) known to
interfere with the absorption, distribution, metabolism, or excretion of drugs;

- Clinically significant acute illness or infection within 14 days prior to Day -1;

- Any surgical procedure within 3 months prior to Day -1, that may interfere with the
performance in the study in the judgment of the investigator;

- History or presence of cardiac abnormalities or congenital long QT syndrome;

- Subjects with a QTcF interval >450 msec for males and >470 msec for females at
screening or Day -1;

- Any dietary restriction, intolerance, or food allergy that would prohibit the
consumption of a high fat breakfast (food effect cohort only);

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cortexyme Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is a randomized, double-blind, placebo-controlled, single and multiple ascending
dose study to assess the safety and tolerability of COR588 HCl in healthy male and female
subjects.
Trial website
https://clinicaltrials.gov/show/NCT04920903
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joanna Bolger, MS
Address 0 0
Country 0 0
Phone 0 0
1-858-248-5124
Fax 0 0
Email 0 0
jbolger@cortexyme.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04920903