Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RPH-203 Following a Single Dose in Healthy Male Volunteers

Exclusion Criteria30

• Family history of premature Coronary Heart Disease (CHD)
• Any condition requiring the regular use of any medication
• Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 14 days prior to screening
• Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to randomization
• Participation in another study with any investigational product within 30 days or 5 half-lives of the investigational product, whichever is greater, before Day 1 of study treatment
• Treatment in the previous 3 months with any drug known to have a well defined potential for toxicity to a major organ
• Current smoker of more than 10 cigarettes or equivalent / day prior to commencing the study, unable to completely stop smoking during the study
• Be in the exclusion period of any previous study with investigational drugs
• Symptoms of a clinically significant illness in the 3 months before the study
• History of significant allergic disease (e.g. medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization or any food allergy.
• History of autoimmune diseases, such as psoriasis, rheumatoid arthritis, inflammatory bowel disease, etc.
• History of any disease that is known to affect bone, excluding history of bone fracture more than 12 months before the study
• History of renal insufficiency or hepatic insufficiency
• Hypocalcaemia or relevant medical history predisposing volunteers to hypocalcaemia
• Blood or plasma donation of more than 500 ml during the previous 2 months before randomization and/or more than 50 ml in the 2 weeks prior to screening
• Current or history of malignancy disease
• Volunteers at risk for tuberculosis (TB), specifically volunteers with:
• Current clinical, radiographic or laboratory evidence of active TB
• History of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type
• Latent TB which has not been successfully treated
• A positive Quantiferon (Registered Trademark) test at screening or within 6 months prior to Day 1
• Positive test for HIV or prior positive test as confirmed by history
• Positive test for hepatitis B (antigens HBs, antibody HBc) or C, unless caused by immunization
• Current evidence of drug abuse or history of drug abuse within one year prior to screening
• History of alcohol abuse or active alcoholism within 1 year prior to screening i.e. consumption of more than 3 standard drinks per day
• Positive alcohol or urine drug screen at screening
• Mental condition rendering the volunteer incapable to understand the nature, scope, and possible consequences of the study
• Adults under guardianship and people with restriction of freedom by administrative or legal decisions
• Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
• Volunteer is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.