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

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 - CCX507-H SAD/FE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36896

Enrollment

Registered

2012-11-19

Start date

2012-11-28

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Crohn's disease Inflammatory bowel diseases

Interventions

Cohort 1: 3 mg CCX507-H or placebo as dosing solution in the fasted state Cohort 2: 10 mg CCX507-H or placebo as dosing solution in the fasted state Cohort 3a: 30 mg CCX507-H or placebo as dosing solu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics: Effective amount of CCX507 and/or metabolites, PK/PD ratio Pharmacokinetics: CCX507 concentrations (and possible metabolites), plasma/urine concentration Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)