A first in human study assessing the safety and pharmacokinetics (blood levels) of RA101495.

Phase 1

Completed

• Conditions: Paroxysmal nocturnal hemoglobinuria; Blood - Haematological diseases

• Registration Number: ACTRN12615001143516
• Lead Sponsor: Clinical Network Services Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified