Healthy SubjectsPhase 1NCT04183491
Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products
A Phase 1 study testing Interferon beta-1a and Peginterferon beta-1a in people with Healthy Subjects and Pharmacokinetics, run by Food and Drug Administration (FDA) at 1 site in United States.
Trial summary
This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Pharmacokinetics, Pharmacodynamics
- What is being tested?
- Interferon beta-1a and Peginterferon beta-1a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2020to 26 Jan 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject signs an institutional review board (IRB) approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization) before any study related procedures are performed.
- Subject is a healthy man or woman, 18 to 55 years of age, inclusive, who has a body mass index of 18.5 to 29.9 kg/m2, inclusive, at Screening.
- Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at Screening or, if abnormal, the abnormality is not considered clinically significant (as determined and documented by the investigator or designee).
- Subject must have a negative test result for alcohol and drugs of abuse at screening and Check-in (Day -1).
- Female subjects must be of non-childbearing potential or, if they are of childbearing potential, they must: 1) have been strictly abstinent for 1 month before Check in (Day -1) and agree to remain strictly abstinent for the duration of the study and for at least 1 month after the last application of study drug; OR 2) be practicing 2 highly effective methods of birth control (as determined by the investigator or designee; one of the methods must be a barrier technique) from at least 1 month before Check in (Day -1) until at least 1 month after the last application of study drug.
- Female subjects must not be pregnant or lactating before enrollment in the study.
- Male subjects must agree to practice 1 highly effective method of birth control (as determined by the investigator or designee) from at least 1 month before Check-in (Day -1) until at least 1 month after the end of study
- Subject is highly likely (as determined by the investigator) to comply with the protocol defined procedures and to complete the study.
Who cannot join
- Subject has had previous exposure to the biologic Avonex or Plegridy.
- Subject is anemic (i.e., with Hct or Hgb considered clinically significant by Investigator or chronic history of anemia) or has any chronic condition(s) that may impact blood sample collection.
- Subject has a history of asthma.
- Subject has a history of anaphylaxis from environmental exposures such as peanuts or bee stings.
- Subject has an allergic history that includes urticaria, angioedema or respiratory coughing or bronchospasm.
- Subject has a history of severe local reactions or generalized erythema from skin allergen testing.
Show all 29Show fewer
- Subject has used any prescription or nonprescription drugs (including aspirin or NSAIDs and excluding oral contraceptives and acetaminophen) within 14 days or 5 half-lives (whichever is longer) or complementary and alternative medicines within 28 days before the first dose of study drug.
- Subjects are currently participating in another clinical study of an investigational drug or are have been treated with any investigational drug within 30 days or 5 half-lives (whichever is longer) of the compound.
- Subject has used nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff) within 6 weeks of Screening.
- Subject has consumed alcohol, xanthine containing products (e.g., tea, coffee, chocolate, cola), caffeine, grapefruit, or grapefruit juice within 48 hours of dosing. Subjects must refrain from ingesting these throughout the study.
- Subject has any underlying disease or surgical or medical condition (e.g., cancer, human immunodeficiency virus [HIV], severe hepatic or renal impairment) that could put the subject at risk or would normally prevent participation in a clinical study. This includes subjects with any underlying medical conditions that put subjects at higher risk for coronavirus disease of 2019 (COVID-19) complications. Per current Center for Disease Control and Prevention (CDC) recommendations, this includes:
- People with chronic lung disease or moderate to severe asthma
- People who have serious heart conditions
- People who are immunocompromised
- Many conditions can cause a person to be immunocompromised, including cancer treatment, smoking, bone marrow or organ transplantation, immune deficiencies, poorly controlled HIV, and prolonged use of corticosteroids and other immune weakening medications
- People with severe obesity (BMI of 40 or higher)
- People with diabetes
- People with chronic kidney disease undergoing dialysis
- People with liver disease
- Subject has any signs or symptoms that are consistent with COVID-19. Per current CDC recommendations, this includes subjects with the symptoms of cough or shortness of breath or difficulty breathing, or at least two of the following symptoms: fever, chills, repeated shaking with chills, muscle pain, headache, sore throat or new loss of taste/smell. In addition, the subject has any other findings suggestive of COVID-19 risk in the opinion of the investigator.
- Subject tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by a molecular diagnostic test performed prior to admission.
- Subject has been diagnosed with any autoimmune disease or other chronic inflammatory disease.
- Subject has been diagnosed with depression, suicidal ideation or psychosis.
- Subject has been diagnosed with congestive heart failure.
- Subject has been diagnosed with seizures of any type.
- Subject has known or suspected allergies or sensitivities to any study drug.
- Subject has clinical laboratory test results (hematology, serum chemistry lipid panel and comprehensive metabolic panel) at Screening that are outside the reference ranges provided by the clinical laboratory and considered clinically significant by the investigator.
- Subject has a positive test result at Screening for HIV 1 or 2 antibody, hepatitis C virus antibodies, or hepatitis B surface antigen.
- Subject is unable or unwilling to undergo multiple venipunctures for blood sample collection because of poor tolerability or poor venous access.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
Official title: Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 3 - Interferon Beta-1A and Peginterferon Beta-1A
This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies.
This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.
Read the detailed description
This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies.
This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo. Interferon beta-1a doses are 7.5, 15, and 30 µg. Peginterferon beta-1a doses are 31.25, 62.5, and 125 µg. Each arm will include 12 subjects (6 male and 6 female).
Subjects will be admitted for treatment on day -1 and receive a single dose of study drug or placebo on day 1. Depending on the treatment arm, subjects will remain in confinement for 7 days (interferon beta-1a) or 14 days (peginterferon beta-1a and placebo).
Blood samples (approximately 5 mL per sample) will be collected for determination of plasma concentrations for study drug and neopterin levels. Additional blood samples will be collected for determination of lipids (5 mL per sample; pharmacodynamic measure) and exploratory proteomics analyses (5 mL per sample).
Safety evaluations will include adverse event (AE) monitoring, vital sign measurements, and physical examinations. All AEs reported by the subject or observed by the investigator or clinical research unit (CRU) staff will be recorded. Any AE reported after the informed consent is signed and before study drug application will be recorded as medical history.
- Conditions
- Healthy Subjects, Pharmacokinetics, Pharmacodynamics
- Being tested
- Interferon beta-1a, Peginterferon beta-1a, Placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1aBiological
Interferon beta-1a 7.5 µg administered IM
Interferon beta-1aBiological
Interferon beta-1a 15 µg administered IM
Interferon beta-1aBiological
Interferon beta-1a 30 µg administered IM
Peginterferon beta-1aBiological
Peginterferon beta-1a 31.25 µg administered SC
Peginterferon beta-1aBiological
Peginterferon beta-1a 62.5 µg administered SC
Peginterferon beta-1aBiological
Peginterferon beta-1a 125 µg administered SC
PlaceboBiological
Placebo (administered either IM or SC)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Interferon beta-1a low dose | Experimental | Single dose of interferon beta-1a 7.5 µg intramuscular (IM) Receives: Biological: Interferon beta-1a |
| Arm B: Interferon beta-1a intermediate dose | Experimental | Single dose of interferon beta-1a 15 µg IM Receives: Biological: Interferon beta-1a |
| Arm C: Interferon beta-1a high dose | Experimental | Single dose of interferon beta-1a 30 µg IM Receives: Biological: Interferon beta-1a |
| Arm D: Peginterferon beta-1a low dose | Experimental | Single dose of peginterferon beta-1a 31.25 µg subcutaneous (SC) Receives: Biological: Peginterferon beta-1a |
| Arm E: Peginterferon beta-1a intermediate dose | Experimental | Single dose of peginterferon beta-1a 62.5 µg SC Receives: Biological: Peginterferon beta-1a |
| Arm F: Peginterferon beta-1a high dose | Experimental | Single dose of peginterferon beta-1a 125 µg SC Receives: Biological: Peginterferon beta-1a |
| Arm G: Placebo | Placebo comparator | Single dose of placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Effect Curve (AUEC) for Neopterin for Interferon Beta-1a and Peginterferon Beta-1a
The values and variability of standard pharmacodynamic (PD) metric (AUEC [baseline subtracted]) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Maximum Change From Baseline for Neopterin for Interferon Beta-1a and Peginterferon Beta-1a
The values and variability of standard pharmacodynamic (PD) metric (maximal difference at a single time-point) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Secondary outcomes (8)
Area Under the Curve (AUC) for Interferon Beta-1a and Peginterferon Beta-1a
The values and variability of pharmacokinetic characteristic (AUC of free drug concentration) at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Maximum Concentration (Cmax) for Interferon Beta-1a and Peginterferon Beta-1a
The values and variability of pharmacokinetic characteristic (Cmax) at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Area Under Effect Curve (AUEC) for Myxovirus-resistance Protein A (MxA) for Interferon Beta-1a and Peginterferon Beta-1a
The values and variability of standard PD metric (AUEC [baseline subtracted]) for MxA at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Maximum Change From Baseline for Myxovirus-resistance Protein A (MxA) for Interferon Beta-1a and Peginterferon Beta-1a
The values and variability of standard PD metric (maximal difference at a single time-point) for MxA at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Pharmacodynamic Model Parameter, Emax (Maximum Effect), for Neopterin Area Under the Effect Curve Models With Interferon Beta-1a or Peginterferon Beta-1a
Model parameter (Emax) for neopterin area under the effect curve models calculated after combining data from low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a with placebo data. As such, the placebo arm was included in both analyses.
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Pharmacodynamic Model Parameter, ED50 (Half Maximal Effect Dose), for Neopterin Area Under the Effect Curve Models With Interferon Beta-1a or Peginterferon Beta-1a
Model parameter (ED50) for neopterin area under the effect curve models calculated after combining data from low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a with placebo data. As such, the placebo arm was included in both analyses.
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Pharmacodynamic Model Parameter, Emax, for Neopterin Maximum Change From Baseline Models With Interferon Beta-1a or Peginterferon Beta-1a
Model parameter (Emax) for neopterin maximum change from baseline models calculated after combining data from low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a with placebo data. As such, the placebo arm was included in both analyses.
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Pharmacodynamic Model Parameter, ED50, for Neopterin Maximum Change From Baseline Models With Interferon Beta-1a or Peginterferon Beta-1a
Model parameter (ED50) for neopterin maximum change from baseline models calculated after combining data from low, intermediate, and high doses of interferon beta-1a or peginterferon beta-1a with placebo data. As such, the placebo arm was included in both analyses.
Measured: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start28 Feb 2020
- Primary completion26 Jan 2021
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Drug Administration (FDA)
- Sponsor type
- US federal agency
- Collaborators
- Spaulding Clinical Research LLC
- Responsible party
- Sponsor
- Investigators
- Carlos Sanabria, MD, Principal investigator, Spaulding Clinical Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183491
- Sponsor's protocol ID
- SCR-008
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2019
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan is to make data from the study publicly available as a part of manuscript publication. In addition, the protocol and statistical analysis plan will be made available online at this site as well as any eventual publications.
Publications
Mehanna M, Chekka LM, Rosenzweig BA, Samarth DP, Mohamed EG, Raplee I, Sullenberger C, Decker E, Schrieber SJ, Wang YM, Florian J, Hyland PL. Evaluating miRNA Sequencing and Integrative Proteomics for Identifying Plasma miRNAs as Potential Pharmacodynamic Biomarkers of IFNbeta-1a Biologics. Clin Transl Sci. 2025 Dec;18(12):e70444. doi: 10.1111/cts.70444.
PubMed 41420638
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 3 - Interferon Beta-1A and Peginterferon Beta-1A
- ClinicalTrials.gov ID
- NCT04183491
- Acronym / sponsor ID
- SCR-008
- Conditions
- Healthy Subjects, Pharmacokinetics, Pharmacodynamics
- Keywords
- Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Food and Drug Administration (FDA)US federal agency
- Collaborators
- Spaulding Clinical Research LLC
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Posted 22 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies.
This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.
Detailed description
This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies.
This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo. Interferon beta-1a doses are 7.5, 15, and 30 µg. Peginterferon beta-1a doses are 31.25, 62.5, and 125 µg. Each arm will include 12 subjects (6 male and 6 female).
Subjects will be admitted for treatment on day -1 and receive a single dose of study drug or placebo on day 1. Depending on the treatment arm, subjects will remain in confinement for 7 days (interferon beta-1a) or 14 days (peginterferon beta-1a and placebo).
Blood samples (approximately 5 mL per sample) will be collected for determination of plasma concentrations for study drug and neopterin levels. Additional blood samples will be collected for determination of lipids (5 mL per sample; pharmacodynamic measure) and exploratory proteomics analyses (5 mL per sample).
Safety evaluations will include adverse event (AE) monitoring, vital sign measurements, and physical examinations. All AEs reported by the subject or observed by the investigator or clinical research unit (CRU) staff will be recorded. Any AE reported after the informed consent is signed and before study drug application will be recorded as medical history.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Subjects will be randomized to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo
| Arm | Type | Receives |
|---|---|---|
| Arm A: Interferon beta-1a low dose | Experimental | Biological: Interferon beta-1aSingle dose of interferon beta-1a 7.5 µg intramuscular (IM) |
| Arm B: Interferon beta-1a intermediate dose | Experimental | Biological: Interferon beta-1aSingle dose of interferon beta-1a 15 µg IM |
| Arm C: Interferon beta-1a high dose | Experimental | Biological: Interferon beta-1aSingle dose of interferon beta-1a 30 µg IM |
| Arm D: Peginterferon beta-1a low dose | Experimental | Biological: Peginterferon beta-1aSingle dose of peginterferon beta-1a 31.25 µg subcutaneous (SC) |
| Arm E: Peginterferon beta-1a intermediate dose | Experimental | Biological: Peginterferon beta-1aSingle dose of peginterferon beta-1a 62.5 µg SC |
| Arm F: Peginterferon beta-1a high dose | Experimental | Biological: Peginterferon beta-1aSingle dose of peginterferon beta-1a 125 µg SC |
| Arm G: Placebo | Placebo comparator | Biological: PlaceboSingle dose of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject signs an institutional review board (IRB) approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization) before any study related procedures are performed.
- Subject is a healthy man or woman, 18 to 55 years of age, inclusive, who has a body mass index of 18.5 to 29.9 kg/m2, inclusive, at Screening.
- Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at Screening or, if abnormal, the abnormality is not considered clinically significant (as determined and documented by the investigator or designee).
- Subject must have a negative test result for alcohol and drugs of abuse at screening and Check-in (Day -1).
- Female subjects must be of non-childbearing potential or, if they are of childbearing potential, they must: 1) have been strictly abstinent for 1 month before Check in (Day -1) and agree to remain strictly abstinent for the duration of the study and for at least 1 month after the last application of study drug; OR 2) be practicing 2 highly effective methods of birth control (as determined by the investigator or designee; one of the methods must be a barrier technique) from at least 1 month before Check in (Day -1) until at least 1 month after the last application of study drug.
Key exclusion criteria (29 listed)
- Subject has had previous exposure to the biologic Avonex or Plegridy.
- Subject is anemic (i.e., with Hct or Hgb considered clinically significant by Investigator or chronic history of anemia) or has any chronic condition(s) that may impact blood sample collection.
- Subject has a history of asthma.
- Subject has a history of anaphylaxis from environmental exposures such as peanuts or bee stings.
- Subject has an allergic history that includes urticaria, angioedema or respiratory coughing or bronchospasm.
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-1aInterferon beta-1a 7.5 µg administered IM | Biological | Arm A: Interferon beta-1a low dose |
| Interferon beta-1aInterferon beta-1a 15 µg administered IM | Biological | Arm B: Interferon beta-1a intermediate dose |
| Interferon beta-1aInterferon beta-1a 30 µg administered IM | Biological | Arm C: Interferon beta-1a high dose |
| Peginterferon beta-1aPeginterferon beta-1a 31.25 µg administered SC | Biological | Arm D: Peginterferon beta-1a low dose |
| Peginterferon beta-1aPeginterferon beta-1a 62.5 µg administered SC | Biological | Arm E: Peginterferon beta-1a intermediate dose |
| Peginterferon beta-1aPeginterferon beta-1a 125 µg administered SC | Biological | Arm F: Peginterferon beta-1a high dose |
| PlaceboPlacebo (administered either IM or SC) | Biological | Arm G: Placebo |
Primary outcome
Area Under Effect Curve (AUEC) for Neopterin for Interferon Beta-1a and Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
The values and variability of standard pharmacodynamic (PD) metric (AUEC [baseline subtracted]) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Maximum Change From Baseline for Neopterin for Interferon Beta-1a and Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
The values and variability of standard pharmacodynamic (PD) metric (maximal difference at a single time-point) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
8 secondary outcomes
Area Under the Curve (AUC) for Interferon Beta-1a and Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Maximum Concentration (Cmax) for Interferon Beta-1a and Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Area Under Effect Curve (AUEC) for Myxovirus-resistance Protein A (MxA) for Interferon Beta-1a and Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Maximum Change From Baseline for Myxovirus-resistance Protein A (MxA) for Interferon Beta-1a and Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Pharmacodynamic Model Parameter, Emax (Maximum Effect), for Neopterin Area Under the Effect Curve Models With Interferon Beta-1a or Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Pharmacodynamic Model Parameter, ED50 (Half Maximal Effect Dose), for Neopterin Area Under the Effect Curve Models With Interferon Beta-1a or Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Pharmacodynamic Model Parameter, Emax, for Neopterin Maximum Change From Baseline Models With Interferon Beta-1a or Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Pharmacodynamic Model Parameter, ED50, for Neopterin Maximum Change From Baseline Models With Interferon Beta-1a or Peginterferon Beta-1a
Time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41420638Mehanna M, Chekka LM, Rosenzweig BA, Samarth DP, Mohamed EG, Raplee I, Sullenberger C, Decker E, Schrieber SJ, Wang YM, Florian J, Hyland PL. Evaluating miRNA Sequencing and Integrative Proteomics for Identifying Plasma miRNAs as Potential Pharmacodynamic Biomarkers of IFNbeta-1a Biologics. Clin Transl Sci. 2025 Dec;18(12):e70444. doi: 10.1111/cts.70444.
- Individual participant dataSharing planned: Yes. Plan is to make data from the study publicly available as a part of manuscript publication. In addition, the protocol and statistical analysis plan will be made available online at this site as well as any eventual publications.
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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.
Carlos Sanabria, MD principal investigator
Spaulding Clinical Research LLC
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-1a and Peginterferon beta-1a in people with Healthy Subjects and Pharmacokinetics, run by Food and Drug Administration (FDA) at 1 site in United States.
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 8 inclusion and 29 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 22 Apr 2024. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under Effect Curve (AUEC) for Neopterin for Interferon Beta-1a and Peginterferon Beta-1a (time frame: 0, 1, 3, 6, 8, 16, 24, 32, 40, 48, 72, hours post-dose; once daily from Day 4 onwards until 7 days post-dose for Interferon Beta-1a treatment arms (Arms A, B and C) and 14 days post-dose for Peginterferon Beta-1a treatment arms (Arms D, E, and F)). 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 NCT04183491, 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 22 Apr 2024.