Healthy VolunteersPhase 1NCT02048358
Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients
A Phase 1 study testing 2B3-201 and Methylprednisolone hemisuccinate in people with Healthy Volunteers and Multiple Sclerosis, run by BBB-Therapeutics B.V. at 2 sites in Netherlands.
Trial summary
In this first in human study the aim is to assess the safety, pharmacokinetics and pharmacodynamics of 2B3-201 in a randomized, first in human, double-blind, placebo- and active comparator- controlled 3-way crossover study in 18 healthy male subjects (part 1). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Multiple Sclerosis
- What is being tested?
- 2B3-201 and Methylprednisolone hemisuccinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 2 sitesNetherlands
- Study dates
- Nov 2013to Feb 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Healthy male or female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
- Able to participate and willing to give written informed consent and to comply with the study restrictions.
- Relapsing MS patients
- Age: 18 to 65 years, both men and women.
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- Patients with relapsing multiple sclerosis (RMS), defined as below, with an acute exacerbation, who in the opinion of the treating physician should undergo a 3 - 5 day course of high dose methylprednisolone;
- Patients with Relapsing Remitting Multiple Sclerosis (RRMS).
- Patients with Secondary Progressive Multiple Sclerosis (SPMS) and
- Patients with clinically isolated syndromes (CIS) who show dissemination of lesions in time (DIT) and space (DIS) on MRI scans according to the 2010 McDonald criteria.
- Able to participate and willing to comply with the study restrictions. Understands and signs the written informed consent prior to any of the testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
Who cannot join
- Healthy volunteers:
- Any subject who is pregnant or breastfeeding. A urine pregnancy test should be performed in female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) prior to the start of the study treatment.
- For female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male subjects who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) will be a contraindication.
- Not willing to use double-barrier contraception, for the duration of the study and for 3 months after the last dose.
- Positive test for drugs of abuse at screening or pre-dose.
- History of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol) within 3 months of screening. Alcohol consumption will be prohibited during study confinement and at least 48 hours before screening, before dosing, and before each scheduled visit.
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- History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
- Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
- Systolic blood pressure (SBP) greater than 140 mm Hg or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 mm Hg or less than 50 mm Hg.
- Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary supplements within 21 days of study drug administration. Exceptions are paracetamol (up to 4 g/day).
- Use of CYP3A4-inhibiting drugs, including quinine containing drinks (bitter lemon and tonic water) is prohibited within 21 days of study drug administration
- Subject has used grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, or pomelo-containing products, within 14 days prior to day -1.
- Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- Participation in an investigational drug or device study within 3 months prior to screening.
- Donation of blood over 500 mL within three months prior to screening.
- Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
- Smoker of more than 10 cigarettes per day prior to screening or who use tobacco products equivalent to more than 10 cigarettes per day.
- Clinically significant abnormal ECG, as judged by the Investigator.
- Current infection or inflammation study within 1 month prior to screening
- Recent vaccinations study within 3 months prior to screening.
- Positive Mantoux test of 5 mm or more.
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
- Unwillingness or inability to comply with the study protocol for any other reason.
- RMS patients:
- Previous acute exacerbations, and/or corticosteroid treatment or ACTH < 1 month before present exacerbation,
- Hypersensitivity to methylprednisolone.
- Prior use of immunosuppressive treatments / disease-modifying drugs (DMDs) other than interferon-beta, glatiramer acetate, fingolimod, dimethylfumarate or teriflunomide within 12 months of the index episode. Shorter periods may be allowed at the discretion of the PI and after approval from the sponsor. Subjects may continue their current therapy with interferons, glatiramer acetate, fingolimod, or teriflunomide throughout the course of the study.
- Non-steroidal anti-inflammatory agents, including salicylic acid, should be avoided during the administration of the steroid therapy. If absolutely necessary they are permitted for subjects to treat interferon side effects, when the patient is not responding to acetaminophen/paracetamol.
- Current or recent (within 30 days of first study treatment) treatment with any other investigational drug or participation in any other investigational study
- Evidence of psychiatric illness
- History of any significant cardiac, gastrointestinal, hepatic, pulmonary, renal or active immunosuppressive disease.
- Immune deficiency or any other medical conditions that would preclude corticosteroid therapy.
- Any patient who is pregnant or breastfeeding. A urine pregnancy test should be performed in female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) prior to the start of the study treatment.
- For female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male subjects who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) will be a contraindication.
- Physical examination results or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at a high risk of treatment-related complications.
- Known hypersensitivity to any of the cyclodextrin or any excipients in 2B3-201 (e.g. PEG, Cholesterol, HSPC or GSH).
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
VUmc, PET and neurology clinical research unit
Amsterdam, North Holland, 1081 HV
Centre for Human Drug Research (CHDR)
Leiden, 2333 CH
About this study
Official title: Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201
In this first in human study the aim is to assess the safety, pharmacokinetics and pharmacodynamics of 2B3-201 in a randomized, first in human, double-blind, placebo- and active comparator- controlled 3-way crossover study in 18 healthy male subjects (part 1). Furthermore, the findings obtained from part 1 will be extended and confirmed in a subsequent parallel open label study in 18 healthy male and 12 MS patients and an open label study with methylprednisolone as comparator in 12 female volunteers (part 2).
- Conditions
- Healthy Volunteers, Multiple Sclerosis
- Being tested
- 2B3-201, Placebo, Methylprednisolone hemisuccinate
- Keywords
- Healthy volunteers, first in human, 2B3-201, methylprednisolone, CNS-targeting, liposomal, crossover, placebo controlled, active controlled, multiple sclerosis, multiple sclerosis relapse
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2B3-201Drug
Also called 2B3-201: glutathione PEGylated-liposomal methylprednisolone
PlaceboDrug
Also called 5% Dextrose
Methylprednisolone hemisuccinateDrug
Also called Solu-Medrol
| Study group | Role | What they receive |
|---|---|---|
| 2B3-201 150mg | Experimental | 2B3-201 150mg, once, IV infusion in 1000ml 5% dextrose/ Methylprednisolone hemisuccinate 1000mg, once, IV infusion in 1000ml 5% dextrose/ Placebo, once, IV infusion 1000ml 5% dextrose Receives: Drug: 2B3-201; Drug: Placebo; Drug: Methylprednisolone hemisuccinate |
| 2B3-201 300mg | Experimental | 2B3-201 300mg, once, IV infusion in 1500ml 5% dextrose/ Methylprednisolone hemisuccinate 300mg, once, IV infusion in 1500ml 5% dextrose/ Placebo, once, IV infusion 1500ml 5% dextrose Receives: Drug: 2B3-201; Drug: Placebo; Drug: Methylprednisolone hemisuccinate |
| 2B3-201 450mg | Experimental | 2B3-201 450mg, once, IV infusion in 2500ml 5% dextrose/ Methylprednisolone hemisuccinate 1000mg, once, IV infusion in 2500ml 5% dextrose/ Placebo, once, IV infusion 2500ml 5% dextrose Receives: Drug: 2B3-201; Drug: Placebo; Drug: Methylprednisolone hemisuccinate |
| 450mg 2B3-201 | Experimental | 2B3-201 450mg, once, IV infusion in 2500ml 5% dextrose Receives: Drug: 2B3-201 |
| 300mg 2B3-201 | Experimental | 2B3-201 300mg, once, IV infusion in 1500ml 5% dextrose Receives: Drug: 2B3-201 |
| 2B3-201 450mg male volunteers | Experimental | 2B3-201 450mg, once, IV infusion in 1500ml 5% dextrose Receives: Drug: 2B3-201 |
| 2B3-201 300mg or 450mg female volunteers | Experimental | 2B3-201 300mg or 450mg, once, IV infusion in 1500 or 2500ml 5% dextrose/ Methylprednisolone hemisuccinate 1000mg, once, IV infusion in 1500 or 2500ml 5% dextrose Receives: Drug: 2B3-201; Drug: Methylprednisolone hemisuccinate |
| Relapsing MS patients; 2B3-201 450 mg | Experimental | 2B3-201 450mg, once, IV infusion in 2500ml 5% dextrose Receives: Drug: 2B3-201 |
| Relapsing MS patients; 2B3-201 dose tbd | Experimental | 2B3-201 (dose to be determined), once, IV infusion in 5% dextrose Receives: Drug: 2B3-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as a measure of safety and tolerability of 2B3-201
Safety and tolerability of 2B3-201, in comparison to free methylprednisolone hemisuccinate and placebo and the safety and tolerability of 2B3-201amongst the different study populations: healthy male and female subjects and MS patients, additionally the safety and tolerability of 2B3-201 with hydroxypropyl β-cyclodextrin added to the infusion bag will be assessed in healthy male subjects
Measured: 3 weeks
Pharmacokinetics in plasma of intravenously administered 2B3-201 in terms of Cmax, Volume of distribution, half-life (T1/2), area under the plasma concentration-time curve (AUC), Clearance (CL)
Pharmacokinetics of 2B3-201, in comparison to free methylprednisolone hemisuccinate and placebo and the pharmacokinetics of 2B3-201amongst the different study populations: healthy male and female subjects and MS patients. Additionally the pharmacokinetics of 2B3-201 with hydroxypropyl β-cyclodextrin added to the infusion bag will be assessed in healthy male subjects
Measured: 3 weeks
Secondary outcomes (6)
Measure changes in central nervous system (CNS) functioning after intravenous administration of 2B3-201 by using the Neurocart test battery
Neurocart test battery (Pharmaco-EEG, Maze learning, Visual verbal Learning test, Stroop test, Adaptive tracking, VAS Bond \& Lader and VAS Bowdle, Eye movements, LSEQ sleep questionnaire) as a measure of pharmacodynamic effects of 2B3-201 on CNS functioning in comparison to free methylprednisolone hemisuccinate and placebo;
Measured: 3 weeks
Changes in levels of Hypothalamic-pituitary-adrenal (HPA) axis hormones as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Measured: 3 weeks
Changes in levels of fasting blood glucose as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Measured: 3 weeks
Changes in levels of osteocalcin concentrations as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Measured: 3 weeks
Changes in levels of lymphocyte count as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Measured: 3 weeks
Changes in levels of complement factors during infusion as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBB-Therapeutics B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geert-Jan Groeneveld, MD, PhD, Principal investigator, Center for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048358
- Sponsor's protocol ID
- 2B3-201-CR-001
- Other IDs
- 2013-004077-28
- Status last verified
- Feb 2015
- First submitted
- 17 Jan 2014
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaillard PJ, Appeldoorn CC, Rip J, Dorland R, van der Pol SM, Kooij G, de Vries HE, Reijerkerk A. Enhanced brain delivery of liposomal methylprednisolone improved therapeutic efficacy in a model of neuroinflammation. J Control Release. 2012 Dec 28;164(3):364-9. doi: 10.1016/j.jconrel.2012.06.022. Epub 2012 Jun 23.
PubMed 22732475
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201
- ClinicalTrials.gov ID
- NCT02048358
- Acronym / sponsor ID
- 2B3-201-CR-001
- Conditions
- Healthy Volunteers, Multiple Sclerosis
- Keywords
- Healthy volunteers, first in human, 2B3-201, methylprednisolone, CNS-targeting, liposomal, crossover, placebo controlled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 47 participants (actual)
- Lead sponsor
- BBB-Therapeutics B.V.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 Jan 2014 (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.
In this first in human study the aim is to assess the safety, pharmacokinetics and pharmacodynamics of 2B3-201 in a randomized, first in human, double-blind, placebo- and active comparator- controlled 3-way crossover study in 18 healthy male subjects (part 1). Furthermore, the findings obtained from part 1 will be extended and confirmed in a subsequent parallel open label study in 18 healthy male and 12 MS patients and an open label study with methylprednisolone as comparator in 12 female volunteers (part 2).
Study design
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 2B3-201 150mg | Experimental | Drug: 2B3-201, Drug: Placebo, Drug: Methylprednisolone hemisuccinate2B3-201 150mg, once, IV infusion in 1000ml 5% dextrose/ Methylprednisolone hemisuccinate 1000mg, once, IV infusion in 1000ml 5% dextrose/ Placebo, once, IV infusion 1000ml 5% dextrose |
| 2B3-201 300mg | Experimental | Drug: 2B3-201, Drug: Placebo, Drug: Methylprednisolone hemisuccinate2B3-201 300mg, once, IV infusion in 1500ml 5% dextrose/ Methylprednisolone hemisuccinate 300mg, once, IV infusion in 1500ml 5% dextrose/ Placebo, once, IV infusion 1500ml 5% dextrose |
| 2B3-201 450mg | Experimental | Drug: 2B3-201, Drug: Placebo, Drug: Methylprednisolone hemisuccinate2B3-201 450mg, once, IV infusion in 2500ml 5% dextrose/ Methylprednisolone hemisuccinate 1000mg, once, IV infusion in 2500ml 5% dextrose/ Placebo, once, IV infusion 2500ml 5% dextrose |
| 450mg 2B3-201 | Experimental | Drug: 2B3-2012B3-201 450mg, once, IV infusion in 2500ml 5% dextrose |
| 300mg 2B3-201 | Experimental | Drug: 2B3-2012B3-201 300mg, once, IV infusion in 1500ml 5% dextrose |
| 2B3-201 450mg male volunteers | Experimental | Drug: 2B3-2012B3-201 450mg, once, IV infusion in 1500ml 5% dextrose |
| 2B3-201 300mg or 450mg female volunteers | Experimental | Drug: 2B3-201, Drug: Methylprednisolone hemisuccinate2B3-201 300mg or 450mg, once, IV infusion in 1500 or 2500ml 5% dextrose/ Methylprednisolone hemisuccinate 1000mg, once, IV infusion in 1500 or 2500ml 5% dextrose |
| Relapsing MS patients; 2B3-201 450 mg | Experimental | Drug: 2B3-2012B3-201 450mg, once, IV infusion in 2500ml 5% dextrose |
| Relapsing MS patients; 2B3-201 dose tbd | Experimental | Drug: 2B3-2012B3-201 (dose to be determined), once, IV infusion in 5% dextrose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy subjects
- Healthy male or female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
- Able to participate and willing to give written informed consent and to comply with the study restrictions.
- Relapsing MS patients
Key exclusion criteria (36 listed)
- Any subject who is pregnant or breastfeeding. A urine pregnancy test should be performed in female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) prior to the start of the study treatment.
- For female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male subjects who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) will be a contraindication.
- Not willing to use double-barrier contraception, for the duration of the study and for 3 months after the last dose.
- Positive test for drugs of abuse at screening or pre-dose.
- History of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol) within 3 months of screening. Alcohol consumption will be prohibited during study confinement and at least 48 hours before screening, before dosing, and before each scheduled visit.
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 |
|---|---|---|
| 2B3-201Also: 2B3-201: glutathione PEGylated-liposomal methylprednisolone | Drug | 2B3-201 150mg, 2B3-201 300mg, 2B3-201 300mg or 450mg female volunteers, 2B3-201 450mg, 2B3-201 450mg male volunteers, 300mg 2B3-201, 450mg 2B3-201, Relapsing MS patients; 2B3-201 450 mg, Relapsing MS patients; 2B3-201 dose tbd |
| PlaceboAlso: 5% Dextrose | Drug | 2B3-201 150mg, 2B3-201 300mg, 2B3-201 450mg |
| Methylprednisolone hemisuccinateAlso: Solu-Medrol | Drug | 2B3-201 150mg, 2B3-201 300mg, 2B3-201 300mg or 450mg female volunteers, 2B3-201 450mg |
Primary outcome
Number of subjects with adverse events as a measure of safety and tolerability of 2B3-201
Time frame: 3 weeks
Safety and tolerability of 2B3-201, in comparison to free methylprednisolone hemisuccinate and placebo and the safety and tolerability of 2B3-201amongst the different study populations: healthy male and female subjects and MS patients, additionally the safety and tolerability of 2B3-201 with hydroxypropyl β-cyclodextrin added to the infusion bag will be assessed in healthy male subjects
Pharmacokinetics in plasma of intravenously administered 2B3-201 in terms of Cmax, Volume of distribution, half-life (T1/2), area under the plasma concentration-time curve (AUC), Clearance (CL)
Time frame: 3 weeks
Pharmacokinetics of 2B3-201, in comparison to free methylprednisolone hemisuccinate and placebo and the pharmacokinetics of 2B3-201amongst the different study populations: healthy male and female subjects and MS patients. Additionally the pharmacokinetics of 2B3-201 with hydroxypropyl β-cyclodextrin added to the infusion bag will be assessed in healthy male subjects
6 secondary outcomes
Measure changes in central nervous system (CNS) functioning after intravenous administration of 2B3-201 by using the Neurocart test battery
Time frame: 3 weeks
Changes in levels of Hypothalamic-pituitary-adrenal (HPA) axis hormones as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Time frame: 3 weeks
Changes in levels of fasting blood glucose as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Time frame: 3 weeks
Changes in levels of osteocalcin concentrations as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Time frame: 3 weeks
Changes in levels of lymphocyte count as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Time frame: 3 weeks
Changes in levels of complement factors during infusion as a measure of pharmacodynamic effects of 2B3-201 in comparison to free methylprednisolone hemisuccinate and placebo;
Time frame: 3 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Background: PubMed 22732475Gaillard PJ, Appeldoorn CC, Rip J, Dorland R, van der Pol SM, Kooij G, de Vries HE, Reijerkerk A. Enhanced brain delivery of liposomal methylprednisolone improved therapeutic efficacy in a model of neuroinflammation. J Control Release. 2012 Dec 28;164(3):364-9. doi: 10.1016/j.jconrel.2012.06.022. Epub 2012 Jun 23.
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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.
Geert-Jan Groeneveld, MD, PhD principal investigator
Center for Human Drug Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2B3-201 and Methylprednisolone hemisuccinate in people with Healthy Volunteers and Multiple Sclerosis, run by BBB-Therapeutics B.V. at 2 sites in Netherlands.
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 36 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: stopped early, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 was stopped early. Results are not available in the source record.
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?
Number of subjects with adverse events as a measure of safety and tolerability of 2B3-201 (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 NCT02048358, 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 6 Feb 2015.