None listed
Conditions
Brief summary
The purpose of this study is to test the safety and tolerability of new interferon beta-1b product called PF530. Who is it for? You may be eligible to join this study if you are aged between 18 to 50 years and are in good general health. Females must not be pregnant or breastfeeding. Study details The study will consist of two parts (Part I and Part II). Twelve participants will be enrolled in Part I, and the results of this part will determine how many participants will be enrolled in Part II. The study is divided into a screening phase lasting about 4 weeks and an on-study phase. The on-study phase will be broken into 2 periods with at least a 14 day gap (called a wash-out) between each period to ensure that the study drug is completely gone from your body before the next period starts. Doses will be administered subcutaneously (under the skin), with participants receiving PF530 in one period and BETAFERON in the other period. The order in which you receive those doses (i.e. in period 1 or period 2) will be random. The chance of receiving PF530 first compared to BETAFERON is 1:1. Which treatment you receive first (PF530 or BETAFERON) will not be known by the study staff or yourself. The study dose will be given to you by a clinical unit staff member. Study doses will be administered in the abdomen. Initially in Part I, the first 2 participants will receive a randomised dose – one with PF530 and one with BETAFERON - on the morning of Day 1 and will complete 48 hours of monitoring by site staff before the remaining participants receive their dose. This is referred to as a sentinel dosing. Dosing of the remaining participants will depend on safety information obtained from the 2 sentinel participants. Each of the two study periods will include a confinement period of 5 days and 4 nights, commencing the day before your dosing each period. After leaving the clinical unit on Day 4, you will be required to attend the unit at the same time each morning on Days 5, 6 & 7 for a brief appointment. Your total involvement in the study will be approximately 8 weeks. It is anticipated that each visit will last from 1-2 hours depending on the procedures required. These will include: blood and urine sampling; physical examination; vital signs; medical history, concomitant medications and adverse events (AE) assessment; completion of questionnaires.
Interventions
In this study, half the participants will be receive PF530 and the other half, Betaferon comparator in Period 1. After a 14 day washout period, participants will swap over so that those who received PF530 will be receive Betaferon comparator and vice versa in Period 2.
PF530/Betaferon comparator is given as a single dose of 0.25mg given as a subcutaneous injection in both study periods.
The study will consist of two parts (Part I and Part II). Twelve participants will be enrolled in Part I, and
In this study, half the participants will be receive PF530 and the other half, Betaferon comparator in Period 1. After a 14 day washout period, participants will swap over so that those who received PF530 will be receive Betaferon comparator and vice versa in Period 2. PF530/Betaferon comparator is given as a single dose of 0.25mg given as a subcutaneous injection in both study periods. The study will consist of two parts (Part I and Part II). Twelve participants will be enrolled in Part I, and the results of this part will determine how many participants will be enrolled in Part II.
Sponsors
Pfenex Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female aged 18-50 years 3. Females of childbearing potential must agree to use two effective methods of birth control, practice complete abstinence, or confirm sterilization of monogamous male partner 5. Males must have had a documented vasectomy, practice complete abstinence or use a condom and refrain from sperm. 6. Body Mass Index (BMI) greater than or equal to 18.0 and less than or equal to 30.0 kg/metres squared at Screening. 7. 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 conducted at Screening and Day -1. 8. Able to understand and sign the written Informed Consent Form 9. Willing to follow the protocol requirements and comply with protocol restrictions.
Exclusion criteria
1. Female subjects who are pregnant or lactating. 2. 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. 3. History of clinically significant serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicaemia) less than or equal to 90 days prior to first dose. 4. History of recurring oral herpes virus (cold sores) or presence of oral herpes during Screening or at dosing. 5. History of chronic fatigue syndrome or fibromyalgia. 6. Fever (defined as body temperature greater than or equal to 38.0 degrees Celsius) or symptomatic viral or bacterial infection (including upper respiratory tract infection) less than or equal to 30 days prior to dosing. 7. Previous treatment with any interferon product, including investigational use. 8. 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). 9. A calculated creatinine clearance of less than or equal to 70 mL/min according to the Cockcroft-Gault equation. 10. Positive screening test for human immunodeficiency virus (HIV). 11. 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. 12. History of epilepsy, seizure disorder or any unexplained black-outs. 13. History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator). 14. Score of greater than or equal to 8 on either the anxiety or depression sub-scales of the Hospital Anxiety and Depression Scale (HADS) at Screening or Day -1 15. Score of greater than or equal to 9 on the Modified Scale for Suicidal Ideation (MSSI) at Screening or Day -1 16. 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. 17. History of severe allergic or anaphylactic reactions or a known allergy to any component of the interferon beta-1b formulation. 18. History of drug or alcohol abuse less than or equal to 12 months prior to Screening. 19. History of tobacco use less than or equal to 6 months prior to Screening. 20. A positive test for drugs of abuse or alcohol during Screening or prior to dosing. 21. Unwilling or unable to abstain from alcohol from 7 days prior to dosing until end-of-study assessments. 22. 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. 23. Clinically significant abnormal clinical laboratory test values, as determined by the Investigator, or any value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that is above the upper limit of normal, any value of platelets or haemoglobin that is below the lower limit of normal, or any out-of-range value for total white blood cells, serum sodium or potassium. Tests may be repeated once at the discretion of the Investigator. 24. Clinically significant abnormalities in 12-lead ECG. 25. Prior treatment with any investigational drug less than or equal to 30 days prior to dosing (Day 1), or less than or equal to 5 half-lives of the drug (whichever is longer), or current enrolment in any other study treatment or disease study. 26. Vaccinations less than or equal to 30 days prior to dosing. 27. Donation or loss of greater than or equal to 500 mL of blood or plasma within 30 days prior to dosing. 28. Any other reason for which the Principal Investigator considers it is not in the best interest of the participant to undertake the study.
Outcome results
None listed