Healthy SubjectsPhase 1NCT03331900
Study of COR388 HCl in Healthy Subjects
A Phase 1 study testing COR388 in people with Healthy Subjects, run by Cortexyme Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- COR388
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 2 Apr 2018
- 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
Major Inclusion Criteria:
- 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;
- 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;
- Body mass index (BMI) ≥19 to ≤32 kg/m2;
- 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;
- Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study;
- Able to understand and willing to comply with all study requirements, and follow the study medication regimen.
Major Exclusion Criteria:
- 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;
- Need for any concomitant medication (with the exception of hormonal contraceptives as allowed for females of child-bearing potential);
- 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);
- Use of any non-prescription drug and/or herbal supplements within 7 days prior to the first dose of the study;
- History of significant allergic reaction to any drug;
- Participation in another investigational new drug research study within the 30 days prior to the first dose of the study;
- History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator;
- Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
About this study
Official title: A Phase 1 Single Ascending Dose Study of COR388 HCl
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.
- Conditions
- Healthy Subjects
- Being tested
- COR388, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COR388Drug
Administered as oral capsule
PlaceboDrug
Administered as oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| COR388 TBD mg | Active comparator | Not described Receives: Drug: COR388 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration curve (AUC)
Analysis of AUC
Measured: 72 hours
Maximum observed plasma concentration (Cmax)
Analysis of Cmax
Measured: 72 hours
Time of the first occurrence of the maximum observed plasma concentration (Tmax)
Analysis of Tmax
Measured: 72 hours
Secondary outcomes (4)
Incidence of treatment emergent adverse events
Assessment of the incidence and severity of treatment-emergent adverse events.
Measured: 72 Hours
Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin).
Assessment of changes in serum chemistry measures.
Measured: 72 hours
Changes in hematology lab measures (RBC, Hgb, Hct).
Assessment of changes in hematology measures.
Measured: 72 hours
Changes in urinalysis lab parameters (pH, specific gravity, glucose).
Assessment of changes in urinalysis parameters.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start11 Dec 2017
- Primary completion20 Feb 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 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
- NCT03331900
- Sponsor's protocol ID
- COR388-001
- Status last verified
- Apr 2018
- First submitted
- 23 Oct 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Ascending Dose Study of COR388 HCl
- ClinicalTrials.gov ID
- NCT03331900
- Acronym / sponsor ID
- COR388-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cortexyme Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 6 Nov 2017 (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, dose escalation, first-in-human trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| COR388 TBD mg | Active comparator | Drug: COR388 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| COR388Administered as oral capsule | Drug | COR388 TBD mg |
| PlaceboAdministered as oral capsule | Drug | Placebo |
Primary outcome
Area under the plasma concentration curve (AUC)
Time frame: 72 hours
Analysis of AUC
Maximum observed plasma concentration (Cmax)
Time frame: 72 hours
Analysis of Cmax
Time of the first occurrence of the maximum observed plasma concentration (Tmax)
Time frame: 72 hours
Analysis of Tmax
4 secondary outcomes
Incidence of treatment emergent adverse events
Time frame: 72 Hours
Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin).
Time frame: 72 hours
Changes in hematology lab measures (RBC, Hgb, Hct).
Time frame: 72 hours
Changes in urinalysis lab parameters (pH, specific gravity, glucose).
Time frame: 72 hours
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 18 Apr 2018.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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 COR388 in people with Healthy Subjects, run by Cortexyme Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Apr 2018. 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 United States. 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?
Area under the plasma concentration curve (AUC) (time frame: 72 hours). The study lists 3 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 18 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.