HealthyPhase 1/2NCT00542529
Phase I/II, Randomized, Double-Blind, Study of the Progenitor Cell Mobilizing Effects of Imprime PGG™ Injection Administered at Varied Dosing Regimens With G-CSF Versus G-CSF Alone
A Phase 1/2 study testing Imprime PGG TM for Injection in people with Healthy, run by HiberCell, Inc..
Trial summary
This study is a randomized, placebo-controlled, dose-escalation, single-center study evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of 66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7 treatment groups receiving Imprime PGG or placebo… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Imprime PGG TM for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Dec 2006
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18 and 45, inclusive
- Have a body weight of 45 kg to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
- Be healthy based on medical history, physical examination, electrocardiogram (ECG), and clinical laboratory test results
- If female, be non-pregnant and non-nursing. For either gender, the subject must be either sexually inactive (14 days prior to the first dose of study drug and throughout the study) or practicing at least two methods of birth control from the following list of acceptable forms of contraception:
- Surgically sterile subject or partner (bilateral tubal ligation, hysterectomy, bilateral oophorectomy or vasectomy performed at least 6 months prior to first dose of study drug)
- Intrauterine device (IUD) in place for at least 3 months
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- Barrier methods (condom, diaphragm) with spermicide from the time of the subject/partner's last menstrual period and throughout the study
- Hormonal contraceptives for at least 3 months prior to the first dose of study drug
- Has read, understood and signed the IRB-approved informed consent form (ICF)
Who cannot join
- Has a known hypersensitivity to baker's yeast, G-CSF, or E.coli-derived proteins, or has an active yeast infection
- Has any clinical condition that, in the opinion of the investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective
- Has a history of tobacco use within 90 days of the last day of screening (Day -1) or be a known or suspected abuser of alcohol or other drugs/substances of abuse
- Has a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
- Except as otherwise indicated, has taken any prescription medication within 30 days of the last day of screening (Day -1) or over-the-counter medication, herbal preparation, or vitamins within 7 days of the last day of screening (Day -1)
- Has participated in an investigational drug study within 30 days or five half-lives (whichever is longer) of the last day of screening (Day -1), has received G-CSF within 30 days of the last day of screening, or has ever participated in a study with Imprime PGG or Betafectin®
- Has donated or lost more than a unit of blood within 30 days of the last day of screening (Day -1)
About this study
Official title: Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Single-Center Study of the Progenitor Cell Mobilizing Effects of Imprime PGG™ Injection Administered at Varied Dosing Regimens With G-CSF Versus G-CSF Alone in Healthy Subjects
This study is a randomized, placebo-controlled, dose-escalation, single-center study evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of 66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7 treatment groups receiving Imprime PGG or placebo in varied dosing regimens with granulocyte-colony stimulating factor (G-CSF).
- Conditions
- Healthy
- Being tested
- Imprime PGG TM for Injection
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imprime PGG TM for InjectionBiological
Doses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Placebo comparator | Placebo or 2.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days. Receives: Biological: Imprime PGG TM for Injection |
| Cohort 2 | Placebo comparator | Placebo or 4.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days. Receives: Biological: Imprime PGG TM for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
-To determine the safety of Imprime PGG when dosed as part of a standard 4-day regimen of G-CSF assessed via occurrence of adverse events and change from baseline in clinical laboratories, physical examination, vital signs and ECG
Measured: Prospective
Secondary outcomes (1)
-To evaluate the progenitor cell mobilizing efficacy of Imprime PGG when dosed as part of a standard 4-day progenitor cell mobilizing regimen of G-CSF assessed through peripheral blood CD34+ cell counts
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startNov 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiberCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542529
- Sponsor's protocol ID
- BT-CL-PGG-SCM0611
- Status last verified
- Oct 2007
- First submitted
- 10 Oct 2007
- Last updated
- 11 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Single-Center Study of the Progenitor Cell Mobilizing Effects of Imprime PGG™ Injection Administered at Varied Dosing Regimens With G-CSF Versus G-CSF Alone in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00542529
- Acronym / sponsor ID
- BT-CL-PGG-SCM0611
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- HiberCell, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 11 Oct 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 study is a randomized, placebo-controlled, dose-escalation, single-center study evaluating two different doses of Imprime PGG, each in 7 different dosing regimes. A total of 66 subjects will be enrolled into 2 cohorts and, within each cohort, randomized to 1 of 7 treatment groups receiving Imprime PGG or placebo in varied dosing regimens with granulocyte-colony stimulating factor (G-CSF).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Placebo comparator | Biological: Imprime PGG TM for InjectionPlacebo or 2.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days. |
| Cohort 2 | Placebo comparator | Biological: Imprime PGG TM for InjectionPlacebo or 4.0 mg/kg of Imprime PGG dosed in 7 different treatment regimens in combination with G-CSF for up to 4 consecutive days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be between the ages of 18 and 45, inclusive
- Have a body weight of 45 kg to 125 kg, inclusive, and a body mass index less than or equal to 30 kg/m2
- Be healthy based on medical history, physical examination, electrocardiogram (ECG), and clinical laboratory test results
- If female, be non-pregnant and non-nursing. For either gender, the subject must be either sexually inactive (14 days prior to the first dose of study drug and throughout the study) or practicing at least two methods of birth control from the following list of acceptable forms of contraception:
- Has read, understood and signed the IRB-approved informed consent form (ICF)
Key exclusion criteria (7 listed)
- Has a known hypersensitivity to baker's yeast, G-CSF, or E.coli-derived proteins, or has an active yeast infection
- Has any clinical condition that, in the opinion of the investigator, warrants exclusion from the study from a scientific, procedural, or safety perspective
- Has a history of tobacco use within 90 days of the last day of screening (Day -1) or be a known or suspected abuser of alcohol or other drugs/substances of abuse
- Has a positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) test conducted as part of screening
- Except as otherwise indicated, has taken any prescription medication within 30 days of the last day of screening (Day -1) or over-the-counter medication, herbal preparation, or vitamins within 7 days of the last day of screening (Day -1)
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 |
|---|---|---|
| Imprime PGG TM for InjectionDoses of 2.0 and 4.0 mg/kg intravenous Imprime PGG administered over 1-2 hr for up to 4 consecutive days | Biological | Cohort 1, Cohort 2 |
Primary outcome
-To determine the safety of Imprime PGG when dosed as part of a standard 4-day regimen of G-CSF assessed via occurrence of adverse events and change from baseline in clinical laboratories, physical examination, vital signs and ECG
Time frame: Prospective
1 secondary outcome
-To evaluate the progenitor cell mobilizing efficacy of Imprime PGG when dosed as part of a standard 4-day progenitor cell mobilizing regimen of G-CSF assessed through peripheral blood CD34+ cell counts
Time frame: Prospective
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 11 Oct 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Imprime PGG TM for Injection in people with Healthy, run by HiberCell, Inc..
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 9 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 11 Oct 2007. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
-To determine the safety of Imprime PGG when dosed as part of a standard 4-day regimen of G-CSF assessed via occurrence of adverse events and change from baseline in clinical laboratories, physical examination, vital signs and ECG (time frame: Prospective). 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 11 Oct 2007.