Acute Radiation SyndromePhase 1NCT02587442
A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
A Phase 1 study testing RadProtect® in people with Acute Radiation Syndrome, run by Original BioMedicals Co. Ltd. at 1 site in United States.
Trial summary
This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This study is to be conducted at two clinical centers and in conformity with Good Clinical Practice (GCP). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Radiation Syndrome
- What is being tested?
- RadProtect®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each subject must be willing and able to provide written informed consent for the study
- Healthy volunteer subjects of both genders, aged 18-64 years old, and any race/ethnicity
- Subjects with normal blood pressure (between ranges of 120-140/60-80 mmHg) at screening and baseline
- Subjects with a body mass index (BMI) 18-30 kg/m2
- 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
- Female subjects of childbearing potential must have a negative urine pregnancy test at screening
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- Subjects with physiological examination and laboratory values within normal limits (CBC/differential, blood chemistry, iron, Total Iron Binding Capacity (TIBC), urinalysis, ECG and vital signs)
- Subjects with the ability to comprehend and complete the telephone visits, screening, and site visits
- Subjects must be able to adhere to dose and visit schedules
- Subjects who agree to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial.
Who cannot join
- Subjects with any allergic reaction or sensitivity to glutamate acid, polyethylene glycol, or any component of the test article product
- Subjects who consume > five alcoholic beverages per week
- Subjects who are pregnant or lactating
- Subjects who have blood (or urine) levels outside the normal range for any hepatic, renal, hematologic, lipid or coagulation parameters measured.
- Subjects on Hormone Replacement Therapy within the past three months
- Subjects in any other clinical trial or experimental treatment in the past three months
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
Galina Tucker, 410-706-8772, gtucker@snbl-cpc.com
Mohamed Al-Ibrahim
About this study
Official title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This study is to be conducted at two clinical centers and in conformity with Good Clinical Practice (GCP).
- Conditions
- Acute Radiation Syndrome
- Being tested
- RadProtect®
- Keywords
- Acute Radiation Syndrome, ARS, Amifostine, Radio-protectants
- Medical subject headings
- Acute Radiation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadProtect®Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| RadProtect® | Experimental | 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. Receives: Drug: RadProtect® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers.
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.
Measured: Day 0~ Day 28
Secondary outcomes (1)
Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points.
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).
Measured: Day 0 ~ Day 1 (24 hours after dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Radiation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Original BioMedicals Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587442
- Sponsor's protocol ID
- OBM-A01-H001
- Status last verified
- Oct 2015
- First submitted
- 26 Oct 2015
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen CH, Kuo ML, Wang JL, Liao WC, Chang LC, Chan LP, Lin J. CCM-AMI, a Polyethylene Glycol Micelle with Amifostine, as an Acute Radiation Syndrome Protectant in C57BL/6 Mice. Health Phys. 2015 Sep;109(3):242-8. doi: 10.1097/HP.0000000000000326.
PubMed 26222219
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02587442
- Acronym / sponsor ID
- OBM-A01-H001
- Conditions
- Acute Radiation Syndrome
- Keywords
- Acute Radiation Syndrome, ARS, Amifostine, Radio-protectants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Original BioMedicals Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This study is to be conducted at two clinical centers and in conformity with Good Clinical Practice (GCP).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RadProtect® | Experimental | Drug: RadProtect®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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Each subject must be willing and able to provide written informed consent for the study
- Healthy volunteer subjects of both genders, aged 18-64 years old, and any race/ethnicity
- Subjects with normal blood pressure (between ranges of 120-140/60-80 mmHg) at screening and baseline
- Subjects with a body mass index (BMI) 18-30 kg/m2
- 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
Key exclusion criteria (7 listed)
- Subjects with any allergic reaction or sensitivity to glutamate acid, polyethylene glycol, or any component of the test article product
- Subjects who consume > five alcoholic beverages per week
- Subjects who are pregnant or lactating
- Subjects who have blood (or urine) levels outside the normal range for any hepatic, renal, hematologic, lipid or coagulation parameters measured.
- Subjects on Hormone Replacement Therapy within the past three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadProtect®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. | Drug | RadProtect® |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
- Background: PubMed 26222219Chen CH, Kuo ML, Wang JL, Liao WC, Chang LC, Chan LP, Lin J. CCM-AMI, a Polyethylene Glycol Micelle with Amifostine, as an Acute Radiation Syndrome Protectant in C57BL/6 Mice. Health Phys. 2015 Sep;109(3):242-8. doi: 10.1097/HP.0000000000000326.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RadProtect® in people with Acute Radiation Syndrome, run by Original BioMedicals Co. Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandy Kan (+886-2-2697-1713 ext. 223, sandykan@i-obm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers. (time frame: Day 0~ Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.