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

NCT04488900 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-02-15

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

CKD-508 Capsule

Investigational drug

DRUG

Placebo Capsule

Placebo

DRUG

CKD-508 Tablet

Investigational drug

DRUG

Placebo Tablet

Placebo

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2023-07-02
Completion
2023-07-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488900 on ClinicalTrials.gov