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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2023-07-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06727396

Healthy Subjects

RECRUITING PHASE1

Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects

NCT04746287

Healthy Volunteers

COMPLETED PHASE1

A Phase 1 Study of KHN702 Tablets in Healthy Subjects

NCT07044960

Healthy

NOT_YET_RECRUITING PHASE1

A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants

NCT05877053

Healthy Participants

COMPLETED PHASE1

Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects

NCT05492630

Diabetic Nephropathy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1. CKD-508 Capsule in Single Dose

Single dose of CKD-508 capsules

Group Type EXPERIMENTAL

CKD-508 Capsule

Intervention Type DRUG

Investigational drug

Part 1. Placebo Capsule in Single Dose

Single dose of Placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type DRUG

Placebo

Part 2. CKD-508 Tablet in Single Dose

Single dose of CKD-508 tablets for biocompartibility

Group Type EXPERIMENTAL

CKD-508 Tablet

Intervention Type DRUG

Investigational drug

Part 2. Placebo Tablet in Single Dose

Single dose of Placebo tablets for biocompartibility

Group Type PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type DRUG

Placebo

Part 3. CKD-508 Tablet in Single Dose

Single dose of CKD-508 tablets for food effect

Group Type EXPERIMENTAL

CKD-508 Tablet

Intervention Type DRUG

Investigational drug

Part 3. Placebo Tablet in Single Dose

Single dose of Placebo tablets for food effect

Group Type PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type DRUG

Placebo

Part 4. CKD-508 Tablet in Multiple Dose

Multiple dose of CKD-508 tablets

Group Type EXPERIMENTAL

CKD-508 Tablet

Intervention Type DRUG

Investigational drug

Part 4. Placebo Tablet in Multiple Dose

Multiple dose of placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CKD-508 Capsule

Investigational drug

Intervention Type DRUG

Placebo Capsule

Placebo

Intervention Type DRUG

CKD-508 Tablet

Investigational drug

Intervention Type DRUG

Placebo Tablet

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes