Healthy Volunteers Clinical Trial
Official title:
First-in-human, Randomized, Placebo-controlled, Double-blind, Dose-escalation Study of the Safety and Immunogenicity of NasoShield
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation
clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18
to 49 years of age. Subjects will be screened within 28 days of randomization (Day 1). The
study is comprised of 2 parts:
- Part A: Approximately 120 subjects who meet all inclusion and no exclusion criteria and
provide written informed consent will be enrolled into 4 sequential cohorts of 30
subjects each defined by the NasoShield dose (1×108, 1×109, 1×1010, and 1×1011 vp).
Within each cohort (and the sentinel group in the first dose cohort), subjects will be
randomized in a 4:1:1 ratio to receive 1 intranasal dose of NasoShield (Day 1), 1
intranasal dose of placebo (Day 1), or 3 subcutaneous 0.5 mL doses of BioThrax 14 days
apart (Days 1, 15, and 29). NasoShield and placebo will be administered in a
double-blind fashion, and BioThrax will be administered in an open-label fashion.
- Part B: Approximately 25 subjects who meet all inclusion and no exclusion criteria and
provide written informed consent will be randomized in a 4:1 fashion to receive 2
intranasal doses of NasoShield at the highest well tolerated dose from Part A or placebo
21 days apart (Days 1 and 22). NasoShield and placebo will be administered in a
double-blind fashion.
Subjects will return to the investigational site for multiple visits through Day 361. At each
visit, the subject will be asked about the interim medical history and use of any
medications, and safety and immunogenicity assessments will be performed.
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