A Study to Investigate the Safety, Tolerability, PK, and PD of CKD-508 in Healthy Participants

Chong Kun Dang

Status and phase: Enrolling; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: CKD-508 Tablet; Drug: Placebo Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06727396

A104_02PK2405

Details and patient eligibility

About

This Phase 1, randomized, parallel-group, placebo-controlled, double-blinded study aims to evaluate the safety, PK, and PD of CKD-508 when administered multiple times once daily to healthy participants.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The participant is capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.
• Male and female adults aged 18 to 55 years at screening.
• Healthy participants were determined by pre-study medical evaluation and judged by the Investigator.
• Female participants of non-childbearing potential (surgically sterile [hysterectomy or oophorectomy]) or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone [FSH] in the postmenopausal range as confirmed by an FSH test).
• Female participants of childbearing potential who agree to use highly effective method of contraception in the protocol consistently and correctly from screening until the last dose administration of the study intervention.
• Male participants must be unable to procreate (defined as surgically sterile [had a vasectomy] ≥6 months prior screening) or must agree to use a highly effective contraception as detailed in the protocol during the intervention period and for at least 90 days after the study completion and refrain from donating sperm during this period.
• Non-smoker (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (<200 ng/mL) at screening and admission.

Exclusion criteria

• History or evidence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder as determined by the Investigator.
• Presence of any disorder that would interfere with the absorption, distribution, metabolism, or excretion of study intervention as judged by the Investigator.
• Serum alkaline phosphatase (ALP) or total bilirubin ≥upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >ULN at either screening or admission.
• Abnormal renal function with estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 at screening.
• History or presence of clinically significant abnormal cardiac automaticity, heart rhythm, ECG findings, or other relevant conditions that may pose a risk to the participants as judged by the Investigator.
• History of alcohol and/or illicit drug abuse within 2 years before screening or positive urine test for alcohol or positive urine drug test at screening or admission.
• Positive test for HBsAg, HCV RNA, or HIV antibody at screening.
• Currently taking a lipid-modifying medication.
• History of hypersensitivity to CKD-508 or medicinal products with similar chemical structures.
• Individual unlikely to comply with the protocol requirements, instructions, and study-related restrictions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups, including a placebo group

CKD-508 dose level 1

Experimental group

Description:

Multiple dose of CKD-508 tablets

Treatment:

Drug: CKD-508 Tablet

CKD-508 dose level 2

Experimental group

Description:

Multiple dose of CKD-508 tablets

Treatment:

Drug: CKD-508 Tablet

CKD-508 dose level 3

Experimental group

Description:

Multiple dose of CKD-508 tablets

Treatment:

Drug: CKD-508 Tablet

CKD-508 dose level 4

Experimental group

Description:

Multiple dose of CKD-508 tablets

Treatment:

Drug: CKD-508 Tablet

Placebo

Placebo Comparator group

Description:

Multiple dose of placebo tablets

Treatment:

Drug: Placebo Tablet