None listed
Conditions
Brief summary
This is the 2nd human trial in gerilimzumab testing the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gerilimzumab. A single dose of 5 mg gerilimzumab or 20 mg gerilimzumab or placebo is administered at three 4-weekly intervals (D1, 28, 56). Participants are followed through to D84. This is a randomized, double-blind, placebo-controlled, multiple dose study.
Interventions
A total of 18 participants will receive three single subcutaneous doses of gerilimzumab (5 mg or 20 mg) or placebo at Day 1, Day 28, Day 56 .
Each dose will be administered by a train site staff (i.e. nurse) and will be documented in the clinic notes.
Sponsors
Clinical Network Services Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 1. Adult male and/or females, 18 to 45 years of age (inclusive) at the time of screening. 2. Medically healthy with clinically insignificant screening results (e.g. laboratory profiles, medical history, ECGs, physical exam) as judged by the PI. 3. Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 29.9 (kg/m2) (inclusive). 4. Must agree to abstain from alcohol intake 48 hours before administration of study agent and during the inpatient period of the study. 5. Negative urine drug screen /alcohol breath test at Day -1. 6. Non-smokers who have not smoked any cigarettes within 6 months prior to screening. No current use of any nicotine containing product. Cotinine levels less than or equal to 5ng/mL. 7. Voluntary consent to participate in the study. 8. Participants using highly effective, double barrier contraception (both male and female partners) during the study and for 4 months following the last dose of gerilimzumab. Males must not donate sperm for at least 4 months post-dose of the last study treatment. Male partners of female patients and female partners of male patients must also use contraception, if they are of childbearing potential. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle stimulating hormone (FSH) level greater than 40 mIU/mL.
Exclusion criteria
1. Positive testing for TB, HIV, HBsAg, or HCV. 2. Have any known malignancy or history of malignancy, except basal cell skin cancer that has been treated with no evidence of recurrence for at least 3 months before Day 1. 3. Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly. 4. Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study 5. Have evidence of any chronic medical condition (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes). 6. Use of any prescription or over-the counter medication (with the exception of paracetamol) within 7 days of randomization. 7. Have a history of or current elevations in triglycerides that required treatment. 8. Any clinically significant laboratory abnormality 9. Absolute neutrophil count less than 1500/microliter 10. AST or ALT greater than Upper Limit of Normal. One repeat test may be allowed within 7 days at the discretion of the investigator. 11. History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration. 12. Blood donation or significant blood loss within 60 days prior to the first study drug administration. 13. Plasma donation within 7 days prior to the first study drug administration. 14. Administration of IP in another clinical trial within 30 days prior to the first study drug administration. 15. Females who are pregnant or lactating. Females should not breast feed for 6 months after the last dose of gerilimzumab. 16. Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant. 17. History of cerebrovascular disease, coronary artery disease, seizures, or unexplained syncope. 18. Regular alcohol consumption in males >21 units per week and females greater than 14 units per week (1 unit = 0.5 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine). 19. Failure to satisfy the PI of fitness to participate for any other reason. 20. Active infection. 21. History of recurrent infections. 22. Serious local infection or systemic infection within 3 months requiring antibiotic treatment. 23. Any acute illness within 30 days prior to Day 1.
Outcome results
None listed