A Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX507-H in Healthy Male and Female Subjects

Completed

• Conditions: Crohn's disease; Inflammatory bowel diseases; 10017969

• Registration Number: NL-OMON36896
• Lead Sponsor: Chemocentryx

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 31

Inclusion Criteria

healthy male and female
19-65 years inclusive
BMI 18.5 - 30.0 inclusive
non-smoker

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS.
Participation in another drug study within 60 days prior to randomization.
Any donation of blood(products) or significant blood loss within 56 dagen prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics: Effective amount of CCX507 and/or metabolites, PK/PD ratio<br /><br>Pharmacokinetics: CCX507 concentrations (and possible metabolites),<br /><br>plasma/urine concentration<br /><br>Safety: adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>