Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04488900

A104-01DL2001

Details and patient eligibility

About

This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.

Enrollment: 88 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
• Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
• Females of non-childbearing potential (surgically sterile [hysterectomy or oophorectomy] or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test).
• Males must be unable to procreate (defined as surgically sterile [i.e., had a vasectomy ≥6 months prior to screening]) or must agree to use highly effective form of birth control from screening through 90 days after study completion.
• Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months).

Exclusion criteria

• Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee.
• Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
• Subject has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
• Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening Visit.
• Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 8 patient groups, including a placebo group

Part 1. CKD-508 Capsule in Single Dose

Experimental group

Description:

Single dose of CKD-508 capsules

Treatment:

Drug: CKD-508 Capsule

Part 1. Placebo Capsule in Single Dose

Placebo Comparator group

Description:

Single dose of Placebo capsules

Treatment:

Drug: Placebo Capsule

Part 2. CKD-508 Tablet in Single Dose

Experimental group

Description:

Single dose of CKD-508 tablets for biocompartibility

Treatment:

Drug: CKD-508 Tablet

Part 2. Placebo Tablet in Single Dose

Placebo Comparator group

Description:

Single dose of Placebo tablets for biocompartibility

Treatment:

Drug: Placebo Tablet

Part 3. CKD-508 Tablet in Single Dose

Experimental group

Description:

Single dose of CKD-508 tablets for food effect

Treatment:

Drug: CKD-508 Tablet

Part 3. Placebo Tablet in Single Dose

Placebo Comparator group

Description:

Single dose of Placebo tablets for food effect

Treatment:

Drug: Placebo Tablet

Part 4. CKD-508 Tablet in Multiple Dose

Experimental group

Description:

Multiple dose of CKD-508 tablets

Treatment:

Drug: CKD-508 Tablet

Part 4. Placebo Tablet in Multiple Dose

Placebo Comparator group

Description:

Multiple dose of placebo tablets

Treatment:

Drug: Placebo Tablet