Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The main aim of this clinical study is to investigate the safety and tolerability of different dose strengths of IC47 up to 6 months after the first vaccination.
A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.
Full description
This Phase 1 study will be conducted in four groups of 8 healthy subjects at a single study center. 32 subjects will be enrolled. The following table shows the design of the different study groups. The amount of protein shown in the table refers to the total protein content and is comprised of an equal amount of the three individual components.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Written informed consent
- Healthy adults ≥ 18 to </= 65
- female subjects: post-menopausal or practicing reliable methods of contraception during the study
Exclusion criteria
- History of autoimmune diseases and malignancies.
- History of severe hypersensitivity reactions and anaphylaxis.
- Immunodeficiency due to immunosuppressive therapy.
- Infection with HIV, Hepatitis B or Hepatitis C.
- Pregnancy, lactation
- Vulnerable subjects
Trial design
32 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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