Hematopoietic Stem Cell TransplantationPhase 1SNOXA12C101NCT01194934
NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers
A Phase 1 study testing NOX-A12, Filgrastim and NOX-A12 in combination with Filgrastim in people with Hematopoietic Stem Cell Transplantation, run by TME Pharma AG at 1 site in Germany.
Trial summary
This is the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of hematopoietic stem cells (HSC) obtained with… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- NOX-A12, Filgrastim and NOX-A12 in combination with Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Jan 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent signed by the subject.
- Healthy male and female subjects aged 18 to 55 years of any ethnic origin.
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests and ECG. Values out of reference range have to be assessed as not clinically significant (NCS) or clinically significant (CS) by the investigator. Individuals presenting deviating values assessed as not clinically significant may be included.
- Male subjects willing to use contraceptive methods from the time of dosing until 3 months after study drug administration (such as condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository), females must be of non-childbearing potential. Non-childbearing potential is defined as follows: Female subjects must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and follicular stimulating hormone ≥ 35 mIU/mL and serum estradiol ≤25 pg/mL), non-lactating and have a negative pregnancy test.
- Body mass index between 19 and 29 kg/m2 (extremes included).
- Body weight between 50 and 100 kg (extremes included).
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- Calculated creatinine clearance ≥ 90 mL/min according to the Cockcroft-Gault-formula.
- Normal lung function (FVC and FEV1 at least 80% of predicted values) at screening.
- O2 saturation between 96% and 100% (extremes included) at screening.
- The subject is co-operative and available for the entire study.
Who cannot join
- Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, hematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation.
- History of general malignant diseases.
- History of renal calculus.
- Hypersensitivity to drugs, atopic eczema, allergic bronchial asthma or any clinically significant allergic disease (excluding non-active hayfever).
- Hypersensitivity to the active substances or to any of its excipients.
- Subjects having already received G-CSF in the past.
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- Intake of vitamin A derivates or retinoids within 30 days prior to the start of study drug administration.
- Subjects who have a significant history of sensitivity to natural sunlight or artificial light such as ultraviolet (UV) light from sunbeds.
- History of thrombosis or increased bleeding risk.
- Laboratory test results outside the reference values as laid down by the study center, which may be an evidence of disease. Positive result of HIV1/2, HCV antibody or HBs antigen testing.
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as QTcB interval >450 msec (females) and >430 msec (males), 2nd or 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as PR<110 msec, confirmed by a repeated ECG.
- Subjects who have had a clinically significant illness within 8 weeks prior to the start of study drug administration as determined by the investigator.
- History of relevant heart disorders or evidence of hyper- or hypotension (supine blood pressure systolic >140 mmHg or <95 mmHg or diastolic >90 mmHg or <65 mmHg at screening).
- Bradycardia or bradyarrhythmia (heart rate after 3 minutes supine rest <45/min at screening).
- Tachycardia or Tachyarrhythmia (heart rate after 3 minutes supine rest >90/min at screening).
- Chronic infection or acute infection or fever within the last 8 weeks prior to the start of study drug administration as determined by the investigator.
- Subjects who have received any prescribed systemic or topical medication within 14 days prior to dose administration as stated by the subject at screening, unless the medication will not interfere with the study procedures or compromise safety as assessed by an investigator in consultation with the sponsor.
- Subjects who have received any medications (including St John's Wort) known to chronically alter drug absorption or elimination processes within 30 days prior to study drug administration as stated by the subject at screening, unless the medication will not interfere with the study procedures or compromise safety as assessed by an investigator in consultation with the sponsor.
- Single use of any medication (including OTC) that are not expressively permitted within two weeks prior to scheduled admission to the study (self-medication or prescription) as stated by the subject at screening, unless the medication will not interfere with the study procedures or compromise safety as assessed by an investigator in consultation with the sponsor.
- Abuse of alcohol (equivalent to more than 18 units per week, where 1 unit is equivalent to one beer (about 330 ml) or one wine (about 150 ml) or one drink (about 40 ml)), caffeine (equivalent to more than 750 mg per day) or tobacco (equivalent to more than 10 cigarettes a day).
- Alcohol breath test positive at screening.
- Drug addiction, positive drug screening in urine.
- Participation in another clinical investigation or being in the restriction period after a clinical investigation.
- Blood donation of more than 100 ml or a comparable blood loss within three months prior to study drug administration.
- Subjects who are known or suspected (i) not to comply with the study directives, (ii) not to be reliable or trustworthy, (iii) not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed to, or (iv) to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.
- Subjects with inadequate venous access.
- Subjects who, in the opinion of the investigator, should not participate in the study.
- Subjects with an abnormal splenic size.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label, Repeated Dose, Phase I Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics and the Effect on Mobilization of Hematopoietic Stem Cells of NOX-A12 Alone and in Combination With Filgrastim
This is the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination with filgrastim in healthy subjects. A single center, open-label, repeated dose study design is selected to best address the study objectives.The results from this study will establish the basis for further development of NOX-A12 in lymphoma patients undergoing autologous hematopoietic stem cell transplantation
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- NOX-A12, Filgrastim, NOX-A12 in combination with Filgrastim
- Keywords
- Stem Cell Transplantation, SDF-1, L-oligonucleotide Aptamer, Spiegelmer, Hematopoietic Stem Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX-A12Drug
Also called olaptesed pegol
4 mg/kg daily IV for 5 days
NOX-A12Drug
Also called olaptesed pegol
2 mg/kg daily IV for 5 days
FilgrastimDrug
Also called olaptesed pegol
5 µg/kg SC daily for 5 days
NOX-A12 in combination with FilgrastimDrug
Also called olaptesed pegol
Safe and efficacious dose regimen according to results of groups A and B
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: 2.0 mg/kg NOX-A12 IV every day for 5 days Receives: Drug: NOX-A12 |
| Group B | Experimental | Group B: 4.0 mg/kg NOX-A12 IV every day for 5 days Receives: Drug: NOX-A12 |
| Group C | Active comparator | The treatment groups will enter the study sequentially. The decision on starting groups C and D will be made after groups A and B have been completed and data are available.
Group C: 5 µg/kg filgrastim SC every day for 5 days Receives: Drug: Filgrastim |
| Group D | Experimental | The treatment groups will enter the study sequentially. The decision on starting groups C and D will be made after groups A and B have been completed and data are available.
Group D: Safe and efficacious dose of NOX-A12 IV in combination with filgrastim SC for 5 days Receives: Drug: NOX-A12 in combination with Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
Measured: 1 month
Secondary outcomes (2)
To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
Measured: 1 month
To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- TME Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Fliegert, MD, Study director, TME Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194934
- Sponsor's protocol ID
- SNOXA12C101
- Other IDs
- 2010-020937-14
- Acronym
- SNOXA12C101
- Status last verified
- Jun 2014
- First submitted
- 2 Sep 2010
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Repeated Dose, Phase I Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics and the Effect on Mobilization of Hematopoietic Stem Cells of NOX-A12 Alone and in Combination With Filgrastim
- ClinicalTrials.gov ID
- NCT01194934
- Acronym / sponsor ID
- SNOXA12C101 / SNOXA12C101
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Stem Cell Transplantation, SDF-1, L-oligonucleotide Aptamer, Spiegelmer, Hematopoietic Stem Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TME Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Sep 2010 (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 the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination with filgrastim in healthy subjects. A single center, open-label, repeated dose study design is selected to best address the study objectives.The results from this study will establish the basis for further development of NOX-A12 in lymphoma patients undergoing autologous hematopoietic stem cell transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: NOX-A12Group A: 2.0 mg/kg NOX-A12 IV every day for 5 days |
| Group B | Experimental | Drug: NOX-A12Group B: 4.0 mg/kg NOX-A12 IV every day for 5 days |
| Group C | Active comparator | Drug: FilgrastimThe treatment groups will enter the study sequentially. The decision on starting groups C and D will be made after groups A and B have been completed and data are available. Group C: 5 µg/kg filgrastim SC every day for 5 days |
| Group D | Experimental | Drug: NOX-A12 in combination with FilgrastimThe treatment groups will enter the study sequentially. The decision on starting groups C and D will be made after groups A and B have been completed and data are available. Group D: Safe and efficacious dose of NOX-A12 IV in combination with filgrastim SC for 5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Informed consent signed by the subject.
- Healthy male and female subjects aged 18 to 55 years of any ethnic origin.
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests and ECG. Values out of reference range have to be assessed as not clinically significant (NCS) or clinically significant (CS) by the investigator. Individuals presenting deviating values assessed as not clinically significant may be included.
- Male subjects willing to use contraceptive methods from the time of dosing until 3 months after study drug administration (such as condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository), females must be of non-childbearing potential. Non-childbearing potential is defined as follows: Female subjects must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and follicular stimulating hormone ≥ 35 mIU/mL and serum estradiol ≤25 pg/mL), non-lactating and have a negative pregnancy test.
- Body mass index between 19 and 29 kg/m2 (extremes included).
Key exclusion criteria (28 listed)
- Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, hematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation.
- History of general malignant diseases.
- History of renal calculus.
- Hypersensitivity to drugs, atopic eczema, allergic bronchial asthma or any clinically significant allergic disease (excluding non-active hayfever).
- Hypersensitivity to the active substances or to any of its excipients.
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 |
|---|---|---|
| NOX-A12Also: olaptesed pegol4 mg/kg daily IV for 5 days | Drug | Group B |
| NOX-A12Also: olaptesed pegol2 mg/kg daily IV for 5 days | Drug | Group A |
| FilgrastimAlso: olaptesed pegol5 µg/kg SC daily for 5 days | Drug | Group C |
| NOX-A12 in combination with FilgrastimAlso: olaptesed pegolSafe and efficacious dose regimen according to results of groups A and B | Drug | Group D |
Primary outcome
To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
Time frame: 1 month
2 secondary outcomes
To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
Time frame: 1 month
To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.
Time frame: 1 month
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 26 Jun 2014.
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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.
Frank Fliegert, MD study director
TME Pharma AG
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 NOX-A12, Filgrastim and NOX-A12 in combination with Filgrastim in people with Hematopoietic Stem Cell Transplantation, run by TME Pharma AG at 1 site in Germany.
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 28 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 26 Jun 2014. 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 Germany. 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?
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 and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects. (time frame: 1 month). 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 26 Jun 2014.