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Autologous Stem Cell TransplantationPhase 1NCT00976378

NOX-A12 First-in-human (FIH) Study

A Phase 1 study testing NOX-A12 in people with Autologous Stem Cell Transplantation, run by TME Pharma AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is the first time NOX-A12 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous (IV) doses to healthy male and female subjects. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Autologous Stem Cell Transplantation
What is being tested?
NOX-A12
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteGermany
Study dates
Oct 2009to May 2010
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Informed consent signed by the subject.
  • Healthy subjects aged 18 to 60 years of any ethnic origin.
  • Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests and electrocardiogram. Values out of reference range have to be assessed as not clinically significant (NCS) or clinically significant (CS) by an investigator. Individuals presenting deviating values assessed as NCS may be included.
  • Subjects willing to use contraceptive methods from the time of dosing until 3 months after the final examination (such as condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository), females must be of non-child bearing potential. Non-child bearing potential is defined as follows: Female subjects 50 years of age or less 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. Female subjects 51 years of age or older must be surgically sterile or post-menopausal (defined by a value of follicular stimulating hormone ≥35 mIU/mL, serum estradiol ≤25 pg/mL or no spontaneous menstruation for at least one year before the first dose), non-lactating and have a negative pregnancy test.
  • Body weight in defined relation to height. Body mass index 19 - 29 kg/m2 (extremes included).
  • Calculated creatinine clearance ≥80 mL/min.
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  • Normal lung function (FVC and FEV1 at least 80% of predicted values) at screening.
  • O2 saturation between 96% and 100% (extremes included) at screening.
  • Body weight between 50 and 100 kg (extremes included).
  • 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).
  • Intake of vitamin A derivatives or retinoids within 30 days prior to the start of the study as stated by the subject at screening.
  • Subjects who have a significant history of sensitivity to natural sunlight or artificial light such as ultraviolet (UV) light from sunbeds.
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  • History of thrombosis.
  • 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 repeat ECG.
  • Subjects who have had a clinically significant illness within 4 weeks of the start of dose 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 (pulse rate after 3 minutes supine rest <45/min at screening).
  • Tachycardia or Tachyarrhythmia (pulse rate after 3 minutes supine rest >90/min at screening).
  • Acute infection or fever within the last 4 weeks as stated by the subject at screening.
  • 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.
  • 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 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.
  • 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.
  • 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 a clinical investigation or blood donation of more than 100 mL or a comparable blood loss within the past 12 weeks prior to the start of the study.
  • 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, 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.
  • Increased bleeding risk as assessed at screening based on a standardized questionnaire on bleeding history.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Scope Life Sciences GmbH

    Hamburg

Other trials in Germany

About this study

Official title: NOX-A12 to Mobilize Stem Cells in Healthy Volunteers - A Single-center, Single Dose, Open Label, Dose Escalation Study of Intravenous NOX-A12 in up to 48 Healthy Subjects

This is the first time NOX-A12 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous (IV) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of administration suitable for subsequent studies in the patient population.

Being tested
NOX-A12
Keywords
stromal cell-derived factor-1 (SDF-1), L-oligonucleotide aptamer, Spiegelmer

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

    single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg

  • NOX-A12Drug

    Also called olaptesed pegol

    single IV dose, at efficacious dose level

Study groups in NCT00976378
Study groupRoleWhat they receive
0.05 mg/kg NOX-A12ExperimentalNot described
Receives: Drug: NOX-A12
0.15 mg/kg NOX-A12ExperimentalNot described
Receives: Drug: NOX-A12
0.45 mg/kg NOX-A12ExperimentalNot described
Receives: Drug: NOX-A12
1.35 mg/kg NOX-A12ExperimentalNot described
Receives: Drug: NOX-A12
2.7 mg/kg NOX-A12ExperimentalNot described
Receives: Drug: NOX-A12
5.4 mg/kg NOX-A12ExperimentalNot described
Receives: Drug: NOX-A12
10.8 mg/kg NOX-A12ExperimentalNot described
Receives: Drug: NOX-A12
5.4 mg/kg NOX-A12 plus apheresisExperimentalNot described
Receives: Drug: NOX-A12

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of NOX-A12 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment

    Measured: 1 month

Secondary outcomes (2)

  1. Pharmacokinetic parameters in plasma and urine

    Measured: 1 month

  2. Pharmacodynamic profile

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00976378
Sponsor's protocol ID
SNOXA12C001
Status last verified
May 2013
First submitted
9 Sep 2009
Last updated
26 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

    PubMed 30957581

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NOX-A12 in people with Autologous 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 26 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?

Safety and tolerability of NOX-A12 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment (time frame: 1 month). 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 NCT00976378, 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 26 Jun 2014; AzTrials last refreshed its copy on 29 Oct 2026.

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