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

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 - CKD-506 Phase 1 SAD/MAD/FE/POC study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45538

Enrollment

Registered

2017-03-23

Start date

2016-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory bowel disease rheumatoid arthritis

Interventions

Groups 1, 2, 3, 4 (only the first period), 5 and 6: The SAD part of the study will consist of 1 study period (except for Group 4, see below) during which you will receive either CKD-506 or placebo on

inflammatory bowel disease

rheumatoid arthritis

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
- To assess the safety and tolerability of single and multiple ascending oral doses of CKD-506 in healthy subjects (SAD and MAD parts) - To assess the PK profile of single and multiple ascending oral doses of CKD-506 in healthy subjects (SAD and MAD parts) - To assess the effect of food on the absorption and PK profile of CKD-506 following a single oral dose of CKD-506 in healthy subjects (FE part) - To assess the effect of IBD on the absorption and PK profile of CKD-506 following multiple oral doses of CKD-506 in IBD patients (POC part)	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
- To evaluate the biological activity (PD) of single and multiple ascending doses of CKD-506 in healthy human subjects (SAD and MAD parts) - To evaluate the effect of food on the safety and tolerability of CKD-506 following a single oral dose of CKD-506 in healthy subjects (FE part) - To evaluate the effect of IBD on the safety and tolerability of CKD-506 following multiple oral doses of CKD-506 in IBD patients (POC part) - To evaluate the biological activity (PD) of multiple oral doses of CKD-506 in IBD patients (POC part)	—

Measure

Time frame

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

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)