A Phase I study evaluating safety, tolerability, and immunogenicity of FPP004X (FPP004X-JP-SAR-01)
Recruiting
- Conditions
- Healthy adults and patients with seasonal allergic rhinitis
- Registration Number
- jRCT2031250033
- Lead Sponsor
- FunPep Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 93
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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Safety, tolerability and immunogenicity
- Secondary Outcome Measures
Name Time Method