jRCT2031250033
Recruiting
Not Applicable
A Phase I study evaluating safety, tolerability, and immunogenicity of FPP004X intramuscularly administered (FPP004X-JP-SAR-01)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FunPep Co., Ltd.
- Enrollment
- 93
- Primary Endpoint
- -
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults(Part 1):
- •Males aged >= 18 to < 45 years at the time of consent
- •Body mass index (BMI) >= 18.5 kg/m2 to < 25.0 kg/m2
- •Patients with seasonal allergic rhinitis(Part 2):
- •Males aged >= 18 to < 50 years at the time of consent
- •Body mass index (BMI) >= 17.6 kg/m2 to < 26.5 kg/m2
Exclusion Criteria
- •Subjects who who have participated (been vaccinated) in a clinical trial of an unapproved vaccine within 1 year prior to the start of the clinical trial (starting from the date of administration of the investigational drug)
- •Subjects who have been diagnosed with immunodeficiency or autoimmune disease
- •Subjects who have or have a history of allergic diseases (atopic dermatitis, bronchial asthma, etc.)
- •Subjects who have a history of hypersensitivity to any component of the investigational product
- •Subjects who are judged by the investigator (subinvestigator) to be ineligible for this clinical trial
Outcomes
Primary Outcomes
-
Safety, tolerability and immunogenicity
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