Safety, tolerability and pharmacokinetics of SI-613 knee injections

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Placebo-Controlled, Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of SI-613 Intra-articular Knee Injection in Healthy Caucasian Male Subjects and Healthy Japanese Male Subjects

• IRAS ID

  95976

• Contact name

  Ulrike Lorch

• Sponsor organisation

  Seikagaku Corporation

• Eudract number

  2011-004769-34

• Research summary

  We are conducting a first time into human clinical trial with a new experimental drug called SI-613 for osteoarthiritis. SI-613 will be injected into the knee joints of 64 healthy male volunteers (40 Caucasians and 24 Japanese) aged between 20 and 40 years to find out how safe the drug is and how well it is tolerated at different doses and to measure the levels of SI-613 in the blood of volunteers to see how this changes when the dose of drug is increased. The results from this study will form the basis for decisions for future studies. The study design will be randomised, double-blinded, and placebo-controlled which means volunteers will be allocated randomly (like tossing a coin) to receive either SI-613 or placebo (dummy drug) and neither the doctor or the volunteer will know whether each volunteer has taken the drug or placebo. Increasing doses of SI-613 (3mg, 6mg, 15mg, 30mg or 60 mg) will be given to different groups of volunteers to determine the safety and tolerability of each dose and we will also see whether there are any differences in the way Caucasians and Japanese respond to SI-613. The study will last approximately 7 weeks including the time when we determine who is suitable for taking part in the study, and follow-up at the end of the study. Volunteers will attend our unit for 5 visits in total and will be treated for 8 days, during a residential period. The main clinical assessments will include a physical knee exam and measurement of safety parameters (vital signs, laboratory assessments, ECGs) and specific markers which give us information on how the drug is processed by the body. Volunteers will also be asked how they are feeling throughout the study and the doctor will note any side effects they may experience.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0186

• Date of REC Opinion

  28 Dec 2011

• REC opinion

  Further Information Favourable Opinion