None listed
Conditions
Brief summary
This is a first in human, randomized, placebo-controlled, double-blind, single dose, escalating dose and Multiple-Dose study of the safety and pharmacokinetics of RA101495 in healthy volunteers to evaluate safety of RA101495. There will be up to 5 single dose cohorts with doses of 0.05, 0.10, 0.20, 0.40 and 0.80 mg/kg. There will be up to 2 multiple dose cohorts with doses of 0.20 and 0.40 mg/kg. Study drug will be administered on Day1 for single dose cohorts and on Day1-7 for multiple dose cohorts as a single SC injection and the amount of drug given will depend on the dose of the cohort and the weight of the subject. Each cohort will be dosed a minimum of 7 days for single days cohorts and 14 days for multiple dose cohorts after the first subject in the previous cohort received the last dose. If 2 or more subjects administered RA101495 in a dose cohort experience a dose-limiting toxicity, dose administration in that cohort will stop and escalation to the next dose level will not proceed.
Interventions
Up to 5 cohorts of healthy volunteers will be defined by escalating dose of RA101495.
Cohort 1: 0.05 mg/kg single subcutaneous injection of RA101495 or placebo
Cohort 2: 0.10 mg/kg single subcutaneous injection of RA101495 or placebo
Cohort 3: 0.20 mg/kg single subcutaneous injection of RA101495 or placebo
Cohort 4: 0.40 mg/kg single subcutaneous injection of RA101495 or placebo
Cohort 5: 0.80 mg/kg single subcutaneous injection of RA101495 or placebo
Each subject will receive only one dose of
Up to 5 cohorts of healthy volunteers will be defined by escalating dose of RA101495. Cohort 1: 0.05 mg/kg single subcutaneous injection of RA101495 or placebo Cohort 2: 0.10 mg/kg single subcutaneous injection of RA101495 or placebo Cohort 3: 0.20 mg/kg single subcutaneous injection of RA101495 or placebo Cohort 4: 0.40 mg/kg single subcutaneous injection of RA101495 or placebo Cohort 5: 0.80 mg/kg single subcutaneous injection of RA101495 or placebo Each subject will receive only one dose of study drug as a subcutaneous injection on Day 1 while in the clinic. Subsequently, Up to 2 cohorts of healthy volunteers will be administered: Cohort 6: 0.20 mg/kg once daily for 7 days subcutaneous injection of RA101495 or placebo Cohort 7: 0.40 mg/kg once daily for 7 days subcutaneous injection of RA101495 or placebo
Sponsors
Clinical Network Services Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
*Male or female, equal to, or greater than 18 and equal to or less than 65 years of age. *Able to complete the informed consent procedure, including signing and dating the informed consent form. *Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug. *Females of childbearing potential and males must agree to use effective birth control. Effective contraception will begin at Screening for females and Day 1 for males, and will continue through Day 29 (28 days after dosing). *Should have received vaccination against Neisseria meningitidis (at least two weeks prior to dosing). Applies to subjects in single-dose cohorts 4 and 5 only and multiple dose cohorts 6 and 7.
Exclusion criteria
*Positive throat swab for Neisseria meningitidis at Screening or a prior history of meningitis. *Allergy to ciprofloxacin. *Pregnant or nursing females. *Body mass index < 18.0 kg/m2 or > 34.9 kg/m2. *Surgery requiring general anesthesia within 3 months prior to Screening or during the study. *Loss of > 500 mL of blood (by any process, including donation) within 3 months prior to Screening or blood donation during the study. *Participation in any clinical trial and use of any investigational drug within 3 months prior to Screening. *Use of systemic immune suppressive or immune stimulatory prescription drugs within one month prior to Screening. *Use of any prescription or over-the-counter medication (excludes contraceptive pill) within 7 to 14 days prior to Screening, unless approved by both the investigator and the Sponsor. *Positive test for hepatitis B surface antigen or for antibody to either human immunodeficiency virus-1 or human immunodeficiency virus-2 or hepatitis C virus. *Diagnosis of any systemic infection within 6 months of screening. *History of a malignancy within the past 10 years, evidence of, or required treatment for, cancer (except treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ). *Screening laboratory test results that are abnormal in the opinion of the principal investigator (tests with abnormal results may be repeated once). *Calculated creatinine clearance of < 80 mL/min (based on the Cockcroft-Gault equation). *Confirmed, clinically significant abnormalities on electrocardiogram (tests with abnormal findings may be repeated once). *Diagnosis of significant medical disease (chronic or active within the past 6 months), including, but not limited to: cardiac disease (e.g., unstable angina, myocardial infarction, congestive heart failure, ventricular arrhythmia), uncontrolled seizure disorder, liver disease, chronic infection (e.g., tuberculosis), or uncontrolled diabetes; diseases judged by the investigator as not clinically significant or as fully resolved will be reviewed with the Sponsor. *Clinically significant abnormal findings on vital signs or physical examination (findings judged by the investigator as not clinically significant will be reviewed with the Sponsor). *Use of any recreational drugs within 3 months prior to Screening. *Unable or unwilling to comply with the requirements of the study in the judgment of the investigator.
Outcome results
None listed