A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02587442|
Recruitment Status : Unknown
Verified October 2015 by Original BioMedicals Co. Ltd..
Recruitment status was: Recruiting
First Posted : October 27, 2015
Last Update Posted : October 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Radiation Syndrome||Drug: RadProtect®||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||March 2016|
RadProtect® is not a full-closed micelle, and uses ferrous iron to provide linkage between PEG-b-PGA and amifostine. Transferrin and other related proteins can chelate with ferrous iron and break the micelle releasing amifostine into the blood stream.
This study will evaluate RadProtect® at sequential, escalating dose levels. Once administration is given, study subjects will be followed during 24 hours of hospitalization according to the final injection timing. All subjects will need to return to the hospital for monitoring at 7+2 days after dosing, and follow-up visits by telephone at Day 3, Day 14+2, and Day 28+2 days will need to be conducted.
- Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers. [ Time Frame: Day 0~ Day 28 ]DLT is defined as a subject's symptom worse than a Grade 2, with the exception of the value for Total Protein and Cholesterol that should be determined by the investigator as these values may be affected by diet and there may be no discomfort or immediate risk for subjects. During the telephone visits on Day 3, 14+2, and 28+2 after injection, the study coordinator will confirm the subject's status, report to the investigators, and will schedule extra hospital visits if necessary.
- Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points. [ Time Frame: Day 0 ~ Day 1 (24 hours after dosing) ]PK samples will be obtained from the arm opposite the side of infusion. A total of approximately 4 mL of whole blood per collection time point per subject will be collected for the PK analysis. There will be a total of 10 or 16 times during this study when the sampling times for PK analysis will take place (this will depend on the dosing group).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587442
|Contact: Sandy Kan||+886-2-2697-1713 ext firstname.lastname@example.org|
|Contact: San Tseng||+886-2-2697-1713 ext email@example.com|
|United States, Maryland|
|SNBL Clinical Pharmacology Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Galina Tucker 410-706-8772 firstname.lastname@example.org|
|Principal Investigator: Mohamed Al-Ibrahim|