Chronic Inflammatory DiseasesPhase 1NCT00976729
NOX-E36 First-in-Human (FIH) Study
A Phase 1 study testing NOX-E36 in people with Chronic Inflammatory Diseases and Type 2 Diabetes Mellitus, run by TME Pharma AG.
Trial summary
This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) 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
- Chronic Inflammatory Diseases, Type 2 Diabetes Mellitus, Systemic Lupus Erythematosus
- What is being tested?
- NOX-E36
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2009
- 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
- Healthy male and female subjects
- Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive
- Body weight between 50 and 100 kg inclusive
- Creatinine clearance of greater than 80 mL/min
Who cannot join
- Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods
- Intake of any prescribed systemic or topical medication within 14 days prior to dosing
- Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements)
- Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment
- History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders
About this study
Official title: NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.
- Being tested
- NOX-E36, Placebo
- Keywords
- monocyte chemoattractant protein-1 (MCP-1), L-oligonucleotide aptamer, Spiegelmer
- Medical subject headings
- Diabetes Mellitus, Type 2, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX-E36Drug
single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg
NOX-E36Drug
single SC doses, at safe and tolerable dose level
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo i.v. | Placebo comparator | Not described Receives: Drug: Placebo |
| 0.03 mg/kg i.v. | Experimental | Not described Receives: Drug: NOX-E36 |
| 0.09 mg/kg i.v. | Experimental | Not described Receives: Drug: NOX-E36 |
| 0.25 mg/kg i.v. | Experimental | Not described Receives: Drug: NOX-E36 |
| 0.5 mg/kg i.v. | Experimental | Not described Receives: Drug: NOX-E36 |
| 1.0 mg/kg i.v. | Experimental | Not described Receives: Drug: NOX-E36 |
| 2.0 mg/kg i.v. | Experimental | Not described Receives: Drug: NOX-E36 |
| Placebo s.c. | Placebo comparator | Not described Receives: Drug: Placebo |
| 0.25 mg/kg s.c. | Experimental | Not described Receives: Drug: NOX-E36 |
| 0.5 mg/kg s.c. | Experimental | Not described Receives: Drug: NOX-E36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment
Measured: throughout the entire study
Secondary outcomes (2)
Pharmacokinetic parameters in plasma and urine
Measured: throughout the entire study
Pharmacodynamic profile
Measured: throughout the entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- TME Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grit Landgraf, PhD, Study director, Noxxon AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976729
- Sponsor's protocol ID
- SNOXE36C001
- Status last verified
- Feb 2013
- First submitted
- 11 Sep 2009
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00976729
- Acronym / sponsor ID
- SNOXE36C001
- Keywords
- monocyte chemoattractant protein-1 (MCP-1), L-oligonucleotide aptamer, Spiegelmer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- TME Pharma AGIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Sep 2009 (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 first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Placebo i.v. | Placebo comparator | Drug: Placebo |
| 0.03 mg/kg i.v. | Experimental | Drug: NOX-E36 |
| 0.09 mg/kg i.v. | Experimental | Drug: NOX-E36 |
| 0.25 mg/kg i.v. | Experimental | Drug: NOX-E36 |
| 0.5 mg/kg i.v. | Experimental | Drug: NOX-E36 |
| 1.0 mg/kg i.v. | Experimental | Drug: NOX-E36 |
| 2.0 mg/kg i.v. | Experimental | Drug: NOX-E36 |
| Placebo s.c. | Placebo comparator | Drug: Placebo |
| 0.25 mg/kg s.c. | Experimental | Drug: NOX-E36 |
| 0.5 mg/kg s.c. | Experimental | Drug: NOX-E36 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects
- Body mass index (BMI) between 19.0 and 29.0 kg/m2 inclusive
- Body weight between 50 and 100 kg inclusive
- Creatinine clearance of greater than 80 mL/min
Key exclusion criteria (5 listed)
- Male and female subjects who are not or whose partners are not willing to use appropriate contraception methods
- Intake of any prescribed systemic or topical medication within 14 days prior to dosing
- Intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements)
- Supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, as confirmed by a repeat assessment
- History of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders
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-E36single ascending IV doses, ranging from 0.03 mg/kg to 2.0 mg/kg | Drug | 0.03 mg/kg i.v., 0.09 mg/kg i.v., 0.25 mg/kg i.v., 0.5 mg/kg i.v., 1.0 mg/kg i.v., 2.0 mg/kg i.v. |
| NOX-E36single SC doses, at safe and tolerable dose level | Drug | 0.25 mg/kg s.c., 0.5 mg/kg s.c. |
| Placebo | Drug | Placebo i.v., Placebo s.c. |
Primary outcome
Safety and tolerability of NOX-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment
Time frame: throughout the entire study
2 secondary outcomes
Pharmacokinetic parameters in plasma and urine
Time frame: throughout the entire study
Pharmacodynamic profile
Time frame: throughout the entire study
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 13 Feb 2013.
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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.
Grit Landgraf, PhD study director
Noxxon AG
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NOX-E36 in people with Chronic Inflammatory Diseases and Type 2 Diabetes Mellitus, run by TME Pharma AG.
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 4 inclusion and 5 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 13 Feb 2013. 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 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-E36 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment (time frame: throughout the entire study). 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 13 Feb 2013.