Healthy VolunteersPhase 1NCT04920903
A Single and Multiple Ascending Dose Study of COR588
A Phase 1 study testing COR588 in people with Healthy Volunteers, run by Cortexyme Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- COR588
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Aug 2021to 30 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Healthy Volunteers
- Being tested
- COR588, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COR588Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| COR588 | Experimental | Not described Receives: Drug: COR588 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events.
Assessment of the incidence and severity of treatment-emergent adverse events.
Measured: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin).
Assessment of changes in serum chemistry measures.
Measured: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Changes in hematology lab measures (red blood cell count [RBC], hemoglobin [Hgb], hematocrit [Hct]).
Assessment of changes in hematology measures.
Measured: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Changes in urinalysis lab parameters (pH, specific gravity, glucose).
Assessment of changes in urinalysis parameters.
Measured: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Secondary outcomes (3)
AUC
Area under the concentration-time curve
Measured: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Cmax
Maximum observed drug concentration during a dosing interval
Measured: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Tmax
Time to Cmax
Measured: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start26 Aug 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortexyme Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920903
- Sponsor's protocol ID
- COR588
- Status last verified
- Jul 2022
- First submitted
- 4 Jun 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04920903
- Acronym / sponsor ID
- COR588
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cortexyme Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COR588 | Experimental | Drug: COR588 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COR588Increasing 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. | Drug | COR588 |
| PlaceboPlacebo will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase. | Drug | Placebo |
Primary outcome
Incidence of treatment emergent adverse events.
Time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
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).
Time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Assessment of changes in serum chemistry measures.
Changes in hematology lab measures (red blood cell count [RBC], hemoglobin [Hgb], hematocrit [Hct]).
Time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Assessment of changes in hematology measures.
Changes in urinalysis lab parameters (pH, specific gravity, glucose).
Time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.
Assessment of changes in urinalysis parameters.
3 secondary outcomes
AUC
Time frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Cmax
Time frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Tmax
Time frame: To Day 3 for the single ascending dose phase and to Day 11 for the multiple ascending dose phase.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COR588 in people with Healthy Volunteers, run by Cortexyme Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events. (time frame: Through Day 8 for the single ascending dose phase and through Day 19 for the multiple ascending dose phase.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.