What side effects are associated with this type of intervention?

Common treatments for Acute Radiation Syndrome (ARS) include radioprotective agents, cytokines, and supportive care. Radioprotective agents like RadProtect® are designed to mitigate the effects of radiation exposure. Known side effects of these treatments can include nausea, vomiting, diarrhea, and fatigue. Cytokines, such as granulocyte colony-stimulating factors, may cause bone pain, fever, and injection site reactions. Supportive care, including antibiotics and blood transfusions, can lead to allergic reactions, infections, and transfusion-related complications. Overall, while these treatments aim to reduce the severity of ARS, they come with a range of potential side effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Radiation Syndrome (ARS), focusing on mitigating the effects of radiation exposure. Key approved drugs include Neupogen (filgrastim), Neulasta (pegfilgrastim), and Leukine (sargramostim), which are granulocyte colony-stimulating factors (G-CSFs) used to boost white blood cell counts and reduce the risk of infection following radiation exposure. These treatments are designed to address the hematopoietic syndrome of ARS, which affects the bone marrow. While specific information about RadProtect® is not provided, it is likely being evaluated for similar protective effects against radiation-induced damage.

What other types of research exist?

Promising novel alternatives to RadProtect® for Acute Radiation Syndrome patients include investigational agents such as thrombopoietic growth factors (e.g., romiplostim, eltrombopag) which have shown potential in mitigating radiation-induced damage. Additionally, other radioprotective agents under clinical evaluation may also be considered.

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Radioprotector

RadProtect for Radiation Protection

Phase 1

Waitlist Available

Research Sponsored by Original BioMedicals Co. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or woman of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during screening, while receiving the investigational drug, and for 60 days after stopping the investigational drug

Be between 18 and 65 years old

Must not have

Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, hypertension, hypotension or systolic blood pressure below 80 mmHg, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.

Subjects with any allergic reaction or sensitivity to glutamate acid, polyethylene glycol, or any component of the test article product

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 ~ day 1 (24 hours after dosing)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests RadProtect® in healthy volunteers to ensure it is safe and well-tolerated. The main goal is to observe side effects and determine safe dosage levels.

Who is the study for?

Healthy adults aged 18-64 with normal blood pressure and BMI of 18-30 kg/m^2 can join. They must not have diabetes, heart, liver, or kidney diseases, active cancer, or certain other conditions. Participants need to use reliable contraception and avoid other trials or experimental treatments.

What is being tested?

The trial is testing RadProtect®, a new drug for preventing radiation injury. It's an early-stage study where volunteers receive increasing doses to check the drug's safety and how it moves through the body over time.

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on safety and dosage levels in healthy volunteers, specific side effects are being investigated but are not yet listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using effective birth control and will continue for 60 days after the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of diabetes, blood pressure issues, stroke, seizures, heart, liver, kidney disease, active cancer, blood disorders, clotting problems, or HIV.

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I am allergic to glutamate acid, polyethylene glycol, or ingredients in the test medicine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 ~ day 1 (24 hours after dosing)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 ~ day 1 (24 hours after dosing)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 ~ day 1 (24 hours after dosing) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers.

Secondary study objectives

Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RadProtect®Experimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Radiation Syndrome (ARS) focus on mitigating the damage to bone marrow and promoting hematopoiesis. Thrombopoietic growth factors, such as thrombopoietin (TPO) receptor agonists, play a crucial role by stimulating the production of platelets and other blood cells, thereby reducing the risk of severe thrombocytopenia and enhancing recovery of the hematopoietic system. These agents, like romiplostim, have shown efficacy in animal studies and are approved for use in ARS. Additionally, agents like granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF) are used to boost white blood cell counts, reducing the risk of infections. The importance of these treatments lies in their ability to protect and restore bone marrow function, which is critical for the survival and recovery of ARS patients.

Acute Hospital Encounters in Cancer Patients Treated With Definitive Radiation Therapy.Correlation between acute and late toxicity in 973 prostate cancer patients treated with three-dimensional conformal external beam radiotherapy.