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CompletedPhase 1

A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355

An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects

Assets

CKD-355A / CKD-355B / D324 / D797

Listed sites

1

Recruiting sites

-

Enrollment

60

actual

Study population

Alzheimer’s disease

Key I/E criterion

Age 19-55

Primary endpoints

Cmax of D324AUCt of D324Cmax of D797

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

Org study ID179BE18029
NCT IDNCT03802162

Timeline

Milestones

Study first posted2019-01-14actual
Study start2019-02-15actual
Primary completion2019-05-10actual
Study completion2019-08-31actual
Last update posted2019-10-23actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age19 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Healthy adult older than 19 years and less than 55 years at the time of screening

2. BMI 18.5~29.9 kg/m2 and body weight more than 50kg

3. Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men

4. Subjects who sign on an informed consent form willingly

Exclusion criteria

1. Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.

2. Subjects who have acute disease within 28 days prior to the first administration

3. Subjects who have history that may affect the ADME

4. Subjects who have clinically significant chronic disease

5. Women who are nursing, pregnant or positive on pregnancy test

6. Subjects who have clinically significant allergic diseases

7. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

8. Subjects who are known to be hypersensitive to the drug or its components

9. Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)

10. Subjects with creatinine clearance <60 ml / min

11. Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range

12. Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration

13. Subjects who can not eat standard meals provided by the institution.

14. Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days

15. Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration

16. Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice>1 L / day)

17. Subjects who participate in the other clinical trial within 90 days prior to the first administration

18. Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day)

19. Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial

20. Subjects who is determined unsuitable to participate in this clinical trial by the investigator

Endpoints (10)

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.

Coverage by outcome category

Safety / tolerability / PK
6
Other (unclassified)
4

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Cmax of D324

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

concentration, descriptive

Primary/protocol endpoint

Cmax of D797

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

concentration, descriptive

Secondary/protocol endpoint

Tmax of D324

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

concentration, descriptive

Secondary/protocol endpoint

Tmax of D797

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

concentration, descriptive

Secondary/protocol endpoint

t½ of D324

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

concentration, descriptive

Secondary/protocol endpoint

t½ of D797

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

concentration, descriptive

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

AUCt of D324

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

descriptive

Primary/protocol endpoint/low confidence

AUCt of D797

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

descriptive

Secondary/protocol endpoint/low confidence

Cmin of D324

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

concentration, descriptive

Secondary/protocol endpoint/low confidence

Cmin of D797

Time frame:0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

concentration, descriptive

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.