Acute Radiation SyndromePhase 1NCT00504335
Safety and Pharmacokinetic Study of BIO 300 Capsules
A Phase 1 study testing BIO 300 Capsules in people with Acute Radiation Syndrome, run by Humanetics Corporation.
Trial summary
This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for use starting at 500 mg. 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?
- BIO 300 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Oct 2007
- 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
- Healthy male and female subjects, age 18-64, who have signed the consent form
- Subjects with a body mass index (BMI) 18-30 kg/m2
- Subjects who are willing to abstain from sex or use a barrier method of birth control (Women 1 week, Men 4 months after leaving the trial)
- Subjects with a negative pregnancy test and drug screen
- Subjects with laboratory values within normal limits (CBC/differential, CMP, enzymes, ECG, vital signs, urinalysis)
- Subjects with ability to comprehend and complete the questionnaires and forms
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- Subjects who are likely to comply with study procedures and test article consumption
- Subjects whose schedules permit a 10-12 hour stay in the clinic followed by daily evaluations for one week (7 days)
- Subjects who are available for a 14-day follow up phone call (women) and 4-month follow up phone call (men).
- Subjects who are likely to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial
- Subjects who are likely to follow the low isoflavone diet program
Who cannot join
- · Subjects with any allergic reaction or sensitivity to soy, isoflavones, or any component of the test article product
- Subjects who consume >5 alcoholic beverages per week
- Subjects who are pregnant, lactating, or at risk of becoming pregnant
- Subjects who have blood (or urine) levels outside the normal range for any of the hepatic, renal, hematologic, lipid or coagulation parameters measured.
- Subjects on Hormone Replacement Therapy or Birth Control Pills within the past three months.
- Subjects on any other clinical trial or experimental treatment in the past 3 months
- Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, uncontrolled hypertension, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.
About this study
Official title: A Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profiles of BIO 300 Capsules in Healthy Male and Female Volunteers
This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for use starting at 500 mg.
Read the detailed description
This clinical trial will assess the safety and PK of BIO 300 capsules at doses expected to deliver a radioprotective or therapeutic effect in humans. Humanetics is planning to conduct this Phase I, single dose, dose-escalation (500, 1000, 1500, and 2000 milligrams) study of the safety, tolerability and pharmacokinetics of BIO 300 by recruiting approximately 24 healthy men and women between the ages of 18 and 64 to be enrolled in cohorts of 6 subjects per group. The first cohort will receive one 500 mg BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting at a clinic skilled in this type of Phase I trial. Blood samples will be analyzed for BIO 300 levels, hematology, chemistry, lipid profiles, phosphorus, clotting factors and fibrinogen as well as pancreatic lipase and amylase. Urinalysis will assess kidney function as well as creatinine clearance and BIO 300 clearance. All subjects will be monitored for adverse events and the safety of BIO 300 capsules will be evaluated in this setting. After review of all safety information and provided no clinically significant negative findings are revealed, the second cohort will be treated with 1000mg BIO 300 (two 500mg capsules) using the same PK sampling program. Again safety concerns will be reviewed and provided no clinically significant negative findings are revealed, the third and fourth cohort will be treated with 1500 and 2000 mg, respectively, of BIO 300 using the same PK sampling program.
- Conditions
- Acute Radiation Syndrome
- Being tested
- BIO 300 Capsules
- Keywords
- Acute Radiation Syndrome, Hematopoietic Syndrome, Radiation Injury, BIO 300
- Medical subject headings
- Acute Radiation Syndrome, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO 300 CapsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| 500 BIO 300 capsule | Experimental | The first cohort will receive one 500 BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting Receives: Drug: BIO 300 Capsules |
| 1000 BIO 300 capsule | Experimental | the second cohort will be treated with 1000 mg BIO 300 using the same PK sampling program Receives: Drug: BIO 300 Capsules |
| 1500 BIO 300 capsule | Experimental | the third cohort will be treated with 1500 mg BIO 300using the same PK sampling program Receives: Drug: BIO 300 Capsules |
| 2000 BIO 300 capsule | Experimental | the forth cohort will be treated with 2000 mg BIO 300using the same PK sampling program Receives: Drug: BIO 300 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by lab work and adverse event monitoring
Measured: 1 month for females & 4 months for males
Secondary outcomes (1)
Pharmacokinetic assessment by analyzing patient serum for free and total BIO 300 content at multiple time points.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Investigators
- John L Zenk, MD, Principal investigator, Humanetics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504335
- Sponsor's protocol ID
- MARC006-025
- Status last verified
- Mar 2015
- First submitted
- 19 Jul 2007
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profiles of BIO 300 Capsules in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT00504335
- Acronym / sponsor ID
- MARC006-025
- Conditions
- Acute Radiation Syndrome
- Keywords
- Acute Radiation Syndrome, Hematopoietic Syndrome, Radiation Injury, BIO 300
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Humanetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Jul 2007 (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 trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for use starting at 500 mg.
Detailed description
This clinical trial will assess the safety and PK of BIO 300 capsules at doses expected to deliver a radioprotective or therapeutic effect in humans. Humanetics is planning to conduct this Phase I, single dose, dose-escalation (500, 1000, 1500, and 2000 milligrams) study of the safety, tolerability and pharmacokinetics of BIO 300 by recruiting approximately 24 healthy men and women between the ages of 18 and 64 to be enrolled in cohorts of 6 subjects per group. The first cohort will receive one 500 mg BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting at a clinic skilled in this type of Phase I trial. Blood samples will be analyzed for BIO 300 levels, hematology, chemistry, lipid profiles, phosphorus, clotting factors and fibrinogen as well as pancreatic lipase and amylase. Urinalysis will assess kidney function as well as creatinine clearance and BIO 300 clearance. All subjects will be monitored for adverse events and the safety of BIO 300 capsules will be evaluated in this setting. After review of all safety information and provided no clinically significant negative findings are revealed, the second cohort will be treated with 1000mg BIO 300 (two 500mg capsules) using the same PK sampling program. Again safety concerns will be reviewed and provided no clinically significant negative findings are revealed, the third and fourth cohort will be treated with 1500 and 2000 mg, respectively, of BIO 300 using the same PK sampling program.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 500 BIO 300 capsule | Experimental | Drug: BIO 300 CapsulesThe first cohort will receive one 500 BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting |
| 1000 BIO 300 capsule | Experimental | Drug: BIO 300 Capsulesthe second cohort will be treated with 1000 mg BIO 300 using the same PK sampling program |
| 1500 BIO 300 capsule | Experimental | Drug: BIO 300 Capsulesthe third cohort will be treated with 1500 mg BIO 300using the same PK sampling program |
| 2000 BIO 300 capsule | Experimental | Drug: BIO 300 Capsulesthe forth cohort will be treated with 2000 mg BIO 300using the same PK sampling program |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male and female subjects, age 18-64, who have signed the consent form
Key exclusion criteria (7 listed)
- · Subjects with any allergic reaction or sensitivity to soy, isoflavones, or any component of the test article product
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 |
|---|---|---|
| BIO 300 Capsules | Drug | 1000 BIO 300 capsule, 1500 BIO 300 capsule, 2000 BIO 300 capsule, 500 BIO 300 capsule |
Primary outcome
Safety as assessed by lab work and adverse event monitoring
Time frame: 1 month for females & 4 months for males
1 secondary outcome
Pharmacokinetic assessment by analyzing patient serum for free and total BIO 300 content at multiple time points.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
John L Zenk, MD principal investigator
Humanetics Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIO 300 Capsules in people with Acute Radiation Syndrome, run by Humanetics Corporation.
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 11 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: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by lab work and adverse event monitoring (time frame: 1 month for females & 4 months for males). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015.