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CMS121
CompletedPhase 1Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects
Phase 1 Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of CMS121 and Food Effect in Healthy Volunteers
Lead sponsor
Asset
CMS121
Listed sites
1
Recruiting sites
-
Enrollment
99
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Age 19-85
Primary endpoint
•Safety
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT05318040
NihR01AG074447
Org study IDVG-CMS121-101
Timeline
Milestones
Study first posted2022-04-08actual
Study start2022-05-01actual
Primary completion2022-12-17actual
Study completion2022-12-17actual
Last update posted2023-02-16actual
Assets
Drug assets
Study populations
Who this study enrolls
Alzheimer’s disease
Eligibility
Who can enroll
Minimum age19 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted
Inclusion criteria
To qualify for enrollment, subjects must meet all of the following inclusion criteria:
All Subjects:
•Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the study schedule, requirements, and restrictions.
•Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dosing.
•Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
•In good general health, free from clinically significant medical or psychiatric illness, based on medical/surgical history, physical examination, and clinical laboratory tests.
•All laboratory parameters (serum chemistry, hematology, coagulation, and urinalysis) are within the reference range or considered not clinically significant by the PI, at the screening visit.
•Negative results for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) tests (as outlined in protocol) at the screening visit.
•Female subjects must have negative results for pregnancy test at the screening visit and the first check-in and must not be lactating.
•Able to swallow multiple capsules.
•Adequate venous access in the left or right arm to allow collection of the required blood samples.
Parts 1 (SAD) and 2 (MAD):
•Healthy, adult, male or female, 19-60 years of age, inclusive, at the screening visit.
-Females of childbearing potential .
-Females of non-childbearing potential are defined as follows:
-Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
-hysteroscopic sterilization;
-bilateral tubal ligation or bilateral salpingectomy;
-hysterectomy;
-bilateral oophorectomy. or
-Individuals who are postmenopausal (PMP) with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with PMP status.
•Females of childbearing potential and male subjects must follow protocol-specified contraception guidance.
•Vital signs must be within the protocol-specified ranges.
•No presence of a clinically significant ECG abnormality as judged by the PI or qualified designee and as per protocol-specified ranges.
Part 3 (Elderly):
•Healthy, adult, male or female, 65-85 years of age, inclusive, at the screening visit.
-Females of childbearing potential.
-Females of non-childbearing potential are defined as follows:
-Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
-hysteroscopic sterilization;
-bilateral tubal ligation or bilateral salpingectomy;
-hysterectomy;
-bilateral oophorectomy. or
-Individuals who are postmenopausal (PMP) with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with PMP status.
or
•Individuals who are PMP with amenorrhea for at least 1 year prior to the first dosing and FSH serum levels consistent with PMP status.
-Females of childbearing potential and male subjects must follow protocol specified contraception guidance.
-Vital signs must be within the protocol-specified ranges.
-QTcF interval is ≤450 msec (males) or ≤470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit and prior to the first dosing.
Part 4 (Food Effect):
•Healthy, adult, male or female, 19-60 years of age, inclusive, at the screening visit.
-Females of childbearing potential.
-Females of non-childbearing potential are defined as follows:
-Individuals who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
-hysteroscopic sterilization;
-bilateral tubal ligation or bilateral salpingectomy;
-hysterectomy;
-bilateral oophorectomy. or
-Individuals who are PMP with amenorrhea for at least 1 year prior to the first dosing and FSH serum levels consistent with PMP status.
•Females of childbearing potential and male subjects must follow protocol specified contraception guidance.
•Vital signs must be within the protocol-specified ranges.
•QTcF interval is ≤450 msec (males) or ≤470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit and prior to the first dosing.
•Able to completely consume a standardized high-fat/high-calorie breakfast as required by the study protocol
Exclusion criteria
•Subjects who meet any of the following criteria must be excluded from the study:
All Subjects:
•Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
•History or presence of malignancy within the past 2 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.
•History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study in the opinion of the PI or designee.
•Evidence of clinically relevant medical illness including cardiovascular, hematological, psychiatric, gastrointestinal, hepatic, renal, rheumatologic, autoimmune, endocrine, pulmonary, neurologic or dermatologic disorder in the opinion of the PI or designee.
•History of skin rash(es) associated with the use of any medication(s).
•Any condition (e.g., chronic diarrhea) or prior surgery (e.g., gastric bypass) that could interfere with drug absorption, distribution, metabolism, or excretion.
•Clinically significant surgical procedure within 90 days prior to the screening visit.
•Clinically significant acute illness or infection within 14 days prior to the first dosing.
•History of significant drug allergies including a history of anaphylactic reaction.
•Family history of sudden death in an otherwise healthy individual.
•Positive urine cotinine at the screening visit or at first check-in.
•Excessive use of alcohol, defined as weekly intake in excess of 14 units of alcohol (1 unit = 12 fluid ounces of beer, 5 fluid ounces of wine, or 1.5 fluid ounces [1 shot] of distilled spirits or liquor), within 6 months prior to the screening visit.
•Positive test result for alcohol or drugs of abuse at the screening visit or first check-in, or history of alcohol and/or drug abuse within the past 2 years prior to the screening visit.
•Heavy caffeine drinker (defined as consumption of >5 servings of caffeinated beverages [e.g., coffee, tea, cola, energy drinks] per day).
•Refusal to refrain from strenuous physical activity from screening until first check-in.
•Unwillingness to avoid sun and/or phototherapy exposure for 72 hours after the last dose of study drug.
•Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing.
•Use of any investigational drug or device within 30 days or biologics for 90 days (or 5 half-lives of the drug, whichever is the longer) prior to the first dosing, or currently participating in another study of an investigational drug or biologics, or a medical device.
•Loss or donation of >500 mL blood within 56 days prior to study drug administration, or donation of plasma within 30 days prior to the first dosing.
•Employee or family member of the PI, study site personnel, or Sponsor.
•Any other reason that, in the opinion of the PI, would render the subject unsuitable for study enrollment.
Parts 1 (SAD):
•History or presence of:
-risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome or sudden unexpected cardiac death at a young age);
-sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities;
-ischemic heart disease, symptomatic arrhythmias, or poorly controlled hypertension.
-conditions predisposing to QT prolongation including pathological Q-wave.
•Unable to refrain from or anticipates the use of:
-any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing;
-any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/pharmacodynamic (PD) interaction with study drug;
-any drugs that prolong the QT/QTc interval within 14 days (or 5 half-lives, whichever is longer) prior to the first dosing.
•Allergy to band aids, adhesive dressing, or medical tape.
•Glomerular filtration rate (GFR) ≤ 80 mL/min/1.73 m2, as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Part 2 (MAD):
•History or presence of:
-risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome or sudden unexpected cardiac death at a young age);
-sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities;
-ischemic heart disease, symptomatic arrhythmias, or poorly controlled hypertension.
-conditions predisposing to QT prolongation including pathological Q-wave.
•Unable to refrain from or anticipates the use of:
-any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing;
-any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug;
-any drugs that prolong the QT/QTc interval within 14 days (or 5 half-lives, whichever is longer) prior to the first dosing.
•Is at risk of suicide. Has attempted suicide in the past 12 months or Is at risk of suicide, as determined by the PI, psychiatric interview and/or the baseline C-SSRS.
•Allergy to band aids, adhesive dressing, or medical tape.
•GFR ≤ 80 mL/min/1.73 m2, as estimated by the CKD-EPI equation.
Part 3 (Elderly):
•Is at risk of suicide. Has attempted suicide in the past 12 months or Is at risk of suicide, as determined by the PI, psychiatric interview and/or the baseline C-SSRS.
•Unable to refrain from or anticipates the use of:
-any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. Thyroid hormone replacement medication (refer to protocol) will be allowed;
-any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug.
•GFR ≤ 70 mL/min/1.73 m2, as estimated by the CKD-EPI equation.
Part 4 (Food Effect):
•Is lactose intolerant.
•Unable to refrain from or anticipates the use of:
-any drugs, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing;
-any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of PK/PD interaction with study drug.
•GFR ≤ 80 mL/min/1.73 m2, as estimated by the CKD-EPI equation.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
4 endpointsPrimary/protocol endpoint
Safety: Treatment-emergent adverse events (TEAEs)
Time frame:From baseline through day 8 for SAD cohorts and through day 15 for MAD cohorts
event count, event
Secondary/protocol endpoint
Pharmacokinetics (PK): Blood concentration levels of CMS121
Time frame:From baseline on day 1 through day 4 for SAD cohorts and through day 10 for MAD cohorts
concentration, descriptive
Secondary/protocol endpoint
Pharmacokinetics (PK): Urine concentration levels of CMS121
Time frame:From baseline on day 1 through day 4 for SAD cohorts and through day 10 for MAD cohorts.
concentration, descriptive
Secondary/protocol endpoint
Safety: Effect on electrocardiographic parameters
Time frame:From baseline on day 1 and for 24hr post day 1 dose for SAD cohorts; from baseline on day 1 and for 24hr post-dose after day 7 dose for MAD cohorts.
change from baseline, event
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.