A Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX872-B in Healthy Male and Female Subjects

A Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX872-B in Healthy Male and Female Subjects - CCX872-B SAD/MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37040

Enrollment

Registered

2012-10-25

Start date

2012-10-29

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

Nephropathy nierfalen

Interventions

Period 1: subjects will receive a single dose of CCX872-B as a capsule Period 2: subjects will receive multiple doses of CCX872-B as a capsule once or twice daily for a total of 7 days

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female 18 - 65 years inclusive BMI 18 - 35 kg/m2 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 voor de keuring.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics: - Plasma levels of MCP-1 and possibly MCP-2, 3, 4 and other chemokines and cytokines related to CCR2 biology - Peripheral blood monocyte subset counts Pharmacokinetics: plasma/urine drug concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)