Study Treatment. Screening Up to 2 months 1-2 None (vitamin D in subjects with low vitamin D at baseline) Pretreatment Up to 2 weeks 1 Vitamin D and calcium Treatment 6 months 8 Vitamin D, calcium, Study Medication Follow-up 1 month 1 Vitamin D and calcium Total 9-10 months 11-12 * For the purposes of this study one month is equal to 30 days. The first self-administration of study medication is to occur at the clinical site under observation. On the days of clinic visits, study medication must be administered in the clinic to accommodate pre- and post-administration procedures. In addition, on days of clinic visits, study personnel will evaluate the application/injection site and patch adhesion (if applicable) using the same scales used by the subject. This information is to be entered into the e-CRF and source documents. Upon the removal of the transdermal patch on the days of clinic visits, the used patch will be carefully replaced into the collar assembly using minimal manipulation and will be frozen (-20ºC) for return to the manufacturer (3M, St. Xxxx MN) for further inspection and analysis (Refer to the study operations manual for detailed instructions). On the days when study [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. medication is administered in the subject’s home, the subject is to dispose of the used patch in a sharps container and maintain the foil pouch for return to the study center for accountability purposes. Subjects randomized to the BA058 Injection arm should bring their used and unused BA058 Injection cartridges to each clinic visit for accountability purposes.
Study Treatment. Eligible subjects will receive 56 weeks of treatment with either VI-0521, or matching placebo for daily use.
Study Treatment. RIST4721 RIST4721 is a high-potency antagonist of human CXCR2 as validated in in vitro and in vivo studies. Five Phase 1 clinical studies of RIST4721 in healthy subjects and one Phase 2a study in patients with moderate-to-severe PPP have been completed. Phase 2 studies in subjects with PPP and FMF are ongoing. RIST4721 was generally well tolerated in the clinical setting. For more detailed information on nonclinical and clinical studies with RIST4721 refer to the Investigator’s Brochure (IB).
Study Treatment. Contractor shall supply and maintain drug kits for administration of the magnesium sulfate.
Study Treatment. Magnesium sulfate (Mg) or matching placebo will be administered intravenously with a 16 minute bolus load followed by a 24 hour infusion. The bolus-loading dose will contain 4 grams Mg in 8 ml normal saline. The maintenance infusion will contain 16 grams Mg diluted in 282ml 0.9% normal saline, infused at 12 ml/hr for 24 hours. Paramedics in the field will initiate the bolus-loading dose, administered by slow intravenous push over 16 minutes. The maintenance infusion will be initiated in hospital immediately upon completion of the loading dose. Drug kits will be specially prepared for the study and carried in each participating vehicle. Each kit will include two syringes preloaded with study agent or placebo, one vial containing study agent or placebo, one bag of 250 ml normal saline, a study information sheet, and two preprinted adhesive labels. The two pre-loaded syringes are for the field dose, and will each contain 2 grams Mg in 4 ml normal saline, or matching placebo. These will be administered directly by the paramedics by slow iv push over 16 minutes, including 8 per syringe. The vial is for the in-hospital maintenance dose, and will contain 16 grams of Mg in 32 ml 0.9% normal saline. Emergency Department nursing personnel will add the contents of the vial to the 250 ml saline bag and infuse the trial solution by intravenous cannula over 24 hours using a controlled rate infusion pump. Each of the ~366 ambulances participating in the study will be stocked with two drug kits at all times, one for under one hour patients and the second for 1-2 hour patients. These kits will be color-coded, with green for under 1 hour patients and yellow for 1-2 hour patients. After each patient enrollment, the vehicle will be restocked on the same or following day. Kits will be stored at 15-30 degrees Centigrade in the pharmacy/central warehouse of the Los Angeles City Fire Department. When stocked in rescue vehicles, kits will be stored at ambient temperature (generally 15-30 degrees Centrigrade) for 12 months. Stability analyses show that magnesium sulfate suffers no significant loss of potency when stored at room temperature for a minimum of 60 months. Kits that expire unused in ambulances after 12 months will be replaced. As soon as a patient is enrolled, the enrolling physician will activate the study nurse at the hospital to which the patient is being transported. The study nurse will travel to the receiving hospital to assist Emergency Department and Hospital nur...
Study Treatment
