A first in human study assessing the safety and pharmacokinetics (blood levels) of RA101495.
A Phase I, Randomized, Placebo-Controlled, Double-Blind, Single Dose, Escalating Dose and Multiple-Dose Study of the Safety and Pharmacokinetics of RA101495 in Healthy Volunteers
Clinical Network Services Pty Ltd
40 participants
Nov 26, 2015
Interventional
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria19
- 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.
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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 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
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12615001143516