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

Phase 1

• Conditions: Bone Metastasis; Osteoporosis; Cancer - Bone; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12613000651785
• Lead Sponsor: ucleus Network Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

*Healthy male volunteers age between 18 and 45 years
*Body mass index between 19 and 30 kg/m2
*No clinically significant findings in the medical history and physical examination
*No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant
*Normal ECG, blood pressure and heart rate, unless the Investigator considers any abnormality to be Not Clinically Significant (NCS)
*Negative Quantiferon (Registered Trademark) test
*Informed consent obtained in writing for all volunteers at enrolment into the study

Exclusion Criteria

*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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified