Multiple SclerosisPhase 1NCT02474134
Comparison Study of PF530 and Betaferon in Healthy Subjects
A Phase 1 study testing Interferon beta-1b (PF530, Betaferon) in people with Multiple Sclerosis, run by Pfenex, Inc at 1 site in Australia.
Trial summary
The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1b (PF530, Betaferon)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2015to Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
- Males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
- Participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
- Able to understand and sign the written Informed Consent Form
Who cannot join
- Female subjects who are pregnant or lactating.
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator.
- Previous treatment with any interferon product, including investigational use.
- Participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- Positive screening test for human immunodeficiency virus (HIV).
- Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B infection (defined as positive for hepatitis surface antigen [HBsAg] at Screening). Participants with immunity to hepatitis B (defined as negative HBsAg and positive hepatitis B surface antibody [HBsAb]) are eligible to participate in the study.
Show all 14Show fewer
- History of epilepsy, seizure disorder or any unexplained black-outs.
- History of hypersensitivity or intolerance to paracetamol or non-steroidal anti-inflammatory drugs (NSAID) that would preclude the use of at least 1 of these during the study.
- History of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon β-1b formulation.
- History of drug or alcohol abuse less than or equal to 12 months prior to Screening.
- History of tobacco use less than or equal to 6 months prior to Screening.
- A positive test for drugs of abuse or alcohol during Screening or prior to dosing.
- Unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments.
- Use of any prescription medication, over-the-counter medication, or herbal supplements/products during Screening or throughout study, unless approved by both the Principal Investigator and the Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double-Blind, Randomised, Two-Treatment Cross-over Study Comparing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF530 and Betaferon Administered by Subcutaneous Injection in Healthy Adult Volunteers
The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.
Read the detailed description
This is a double-blind, randomised, two-treatment cross-over study in healthy adult subjects to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of PF530 and Betaferon. Half of the subjects will be randomised to receive PF530 first and Betaferon second, and the other half will be randomised to receive the drugs in reverse sequence. Each study participant will complete two 7-day study periods (Period 1 and Period 2), separated by a 14-day washout period. In Part I of the study, 12 subjects will be enrolled for an initial assessment. In Part II, up to 36 additional subjects may be enrolled.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (PF530, Betaferon)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (PF530, Betaferon)Drug
Also called PF530, Betaferon
Single subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| PF530/Betaferon | Other | Single subcutaneous injection of two interferon beta-1b products (PF530 and Betaferon) 0.25 mg Receives: Drug: Interferon beta-1b (PF530, Betaferon) |
| Betaferon/PF530 | Other | Single subcutaneous injection of two interferon beta-1b products (Betaferon and PF530) 0.25 mg Receives: Drug: Interferon beta-1b (PF530, Betaferon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE) and serious adverse event (SAE) incidence
Measured: 28 Days
Secondary outcomes (5)
Serum area-under-the-curve (AUC) of PF530 and Betaferon
Measured: 72 hours
Serum maximum concentration (Tmax) of PF530 and Betaferon
Measured: 72 hours
Serum half-life (t1/2) of PF530 and Betaferon
Measured: 72 hours
Serum neopterin
Measured: 168 hours
Serum myxovirus resistance protein A
Measured: 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfenex, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, MD, Principal investigator, CMAX, A Division of IDT Australia, LimitedHubert C Chen, MD, Study director, Pfenex, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474134
- Sponsor's protocol ID
- PF530-101
- Status last verified
- Nov 2015
- First submitted
- 17 Mar 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-Blind, Randomised, Two-Treatment Cross-over Study Comparing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF530 and Betaferon Administered by Subcutaneous Injection in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02474134
- Acronym / sponsor ID
- PF530-101
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pfenex, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Jun 2015 (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.
The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.
Detailed description
This is a double-blind, randomised, two-treatment cross-over study in healthy adult subjects to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of PF530 and Betaferon. Half of the subjects will be randomised to receive PF530 first and Betaferon second, and the other half will be randomised to receive the drugs in reverse sequence. Each study participant will complete two 7-day study periods (Period 1 and Period 2), separated by a 14-day washout period. In Part I of the study, 12 subjects will be enrolled for an initial assessment. In Part II, up to 36 additional subjects may be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF530/Betaferon | Other | Drug: Interferon beta-1b (PF530, Betaferon)Single subcutaneous injection of two interferon beta-1b products (PF530 and Betaferon) 0.25 mg |
| Betaferon/PF530 | Other | Drug: Interferon beta-1b (PF530, Betaferon)Single subcutaneous injection of two interferon beta-1b products (Betaferon and PF530) 0.25 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner
- Males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm.
- Participant is free from clinically significant illness or disease as determined by medical and surgical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
- Able to understand and sign the written Informed Consent Form
Key exclusion criteria (14 listed)
- Female subjects who are pregnant or lactating.
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator.
- Previous treatment with any interferon product, including investigational use.
- Participants with a history of malignant disease, including solid tumours and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- Positive screening test for human immunodeficiency virus (HIV).
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 |
|---|---|---|
| Interferon beta-1b (PF530, Betaferon)Also: PF530, BetaferonSingle subcutaneous administration | Drug | Betaferon/PF530, PF530/Betaferon |
Primary outcome
Adverse event (AE) and serious adverse event (SAE) incidence
Time frame: 28 Days
5 secondary outcomes
Serum area-under-the-curve (AUC) of PF530 and Betaferon
Time frame: 72 hours
Serum maximum concentration (Tmax) of PF530 and Betaferon
Time frame: 72 hours
Serum half-life (t1/2) of PF530 and Betaferon
Time frame: 72 hours
Serum neopterin
Time frame: 168 hours
Serum myxovirus resistance protein A
Time frame: 168 hours
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 16 Nov 2015.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
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.
Sepehr Shakib, MD principal investigator
CMAX, A Division of IDT Australia, Limited
Hubert C Chen, MD study director
Pfenex, Inc
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 Interferon beta-1b (PF530, Betaferon) in people with Multiple Sclerosis, run by Pfenex, Inc at 1 site in Australia.
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 14 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 16 Nov 2015. 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 Australia. 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?
Adverse event (AE) and serious adverse event (SAE) incidence (time frame: 28 Days). 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 16 Nov 2015.