A Phase I, Single-Centre, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CH-4051 in healthy male subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

• written informed consent • males, 18-55 years of age • physically and mantally in good state of health • body mass index of 18-30 kg/m2 • no abnormalities found at screening

Exclusion Criteria

• smoking or stopped smoking less than three months ago • drugs and/or alcohol abuse • drinking more than 21 glasses of alcohol per week • surgery in 3 months prior to study • hepatitis B, C or HIV positive • no history of infection with chicken pox • planning to be vaccinated with a (live) vaccine (yellow fever, MMR, and rubella) during the study • use of prescription medication within 4 weeks prior to the first dosing day • previously or currently receiving MTX • use of over-the-counter medication within 2 weeks prior to the first dosing day • vegetarians, vegans and/or having medical dietary restrictions • relevant food or drug hypersensitivity or allergy • having participated in an investigational drug study within 3 months prior to the dosing day • having donated blood within 12 weeks prior to the (first) dosing day • having a significant infection at screening • having an active viral, bacterial or fungal infection on day -1 • raised body temperature (>38 degrees celsius) on day -1 • taking co-trimoxazole or thrimethoprim • MCV > 95 fL • acute significant gastrointestinal symptoms on day -1 or prior to dosing on day 1.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events and tolerability </p><br>

Secondary Outcome Measures

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

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A Phase I, Single-Centre, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CH-4051 in healthy male subjects

Recruitment & Eligibility

Study & Design

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