Healthy adults and patients with seasonal allergic rhinitis
Conditions
Interventions
1. Healthy adults (Part 1):
FPP004X or placebo will be administered twice or three times at 4-week intervals.
2. Patients with seasonal allergic rhinitis (Part 2):
FPP004X or placebo will be administe
Sponsors
Tomioka Hideki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy adults(Part 1): 1. Males aged >= 18 to = 18.5 kg/m2 to = 18 to = 17.6 kg/m2 to < 26.5 kg/m2
Exclusion criteria
Exclusion criteria: 1. 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) 2. Subjects who have been diagnosed with immunodeficiency or autoimmune disease 3. Subjects who have or have a history of allergic diseases (atopic dermatitis, bronchial asthma, etc.) 4. Subjects who have a history of hypersensitivity to any component of the investigational product 5. Subjects who are judged by the investigator (subinvestigator) to be ineligible for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, tolerability and immunogenicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Contacts
Public ContactSatoru Kasahara
FunPep Co., Ltd.
Outcome results
None listed