A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetics (including food effect), pharmacodynamics and proof of concept of CKD-506 in healthy subjects and inflammatory bowel disease patients

Completed

Conditions: inflammatory bowel disease
rheumatoid arthritis
10023213
10017969

Registration Number: NL-OMON45538

Lead Sponsor: Chong Kun Dang Pharmaceutical Corp.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

healthy male or female volunteers, IBD patients
18-55 years, inclusive
BMI: 18.0-32.0 kg/m2, inclusive
non-smoking

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating or losing more than 100 milliliters of blood in the 60 days prior the start of this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To assess the safety and tolerability of single and multiple ascending oral<br /><br>doses of CKD-506 in healthy subjects (SAD and MAD parts)<br /><br>- To assess the PK profile of single and multiple ascending oral doses of<br /><br>CKD-506 in healthy subjects (SAD and MAD parts)<br /><br>- To assess the effect of food on the absorption and PK profile of CKD-506<br /><br>following a single oral dose of CKD-506 in healthy subjects (FE part)<br /><br>- To assess the effect of IBD on the absorption and PK profile of CKD-506<br /><br>following multiple oral doses of CKD-506 in IBD patients (POC part)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate the biological activity (PD) of single and multiple ascending<br /><br>doses of CKD-506 in healthy human subjects (SAD and MAD parts)<br /><br>- To evaluate the effect of food on the safety and tolerability of CKD-506<br /><br>following a single oral dose of CKD-506 in healthy subjects (FE part)<br /><br>- To evaluate the effect of IBD on the safety and tolerability of CKD-506<br /><br>following multiple oral doses of CKD-506 in IBD patients (POC part)<br /><br>- To evaluate the biological activity (PD) of multiple oral doses of CKD-506 in<br /><br>IBD patients (POC part)</p><br>