None listed
Conditions
Brief summary
This is a first in human trial testing the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gerilimzumab. Four doses (1 mg, 5 mg, 15 mg, and 30 mg) will be tested in a sequential manner. After the completion of Day 7 at each dose level, a safety monitoring committee will meet and review blinded data to date. They will decide if the study should continue as planned. Only at that time will the next dose level be enrolled. This is a randomized, double-blind, placebo-controlled, single ascending dose study.
Interventions
This study involves 4 cohorts:
Cohort 1: single subcutaneous dose of 1 mg of gerilimzumab or placebo
Cohort 2: single subcutaneous dose of 5 mg of gerilimzumab of placebo
Cohort 3: single subcutaneous dose of 15 mg of gerilimzumab or placebo
Cohort 4: single subcutaneous dose of 30 mg of gerilimzumab of placebo
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. 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 Principal Investigator. 3. Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 29.9 (kg/m2) . 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 prior to Day -1. 6. Voluntary consent to participate in the study. 7. Participants using highly effective, double barrier contraception (both male and female partners) during the study and for 4 months following the 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. 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 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 greater than 21 units per week and females greater than 14 units per week (1 unit = 1/2 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