A Phase 1, Randomized, Double-blind, Placebo-controlled Assessment of the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Doses of Flufirvitide-3 Dry Powder for Inhalation in Healthy Subjects

Autoimmune Technologies, LLC1 site in 1 country68 target enrollmentMarch 2014

ConditionsInfluenza

InterventionsFlufirvitide 3 Placebo for Flufirvitide-3

DrugsFlufirvitide 3 Placebo for Flufirvitide-3

Overview

Phase: Phase 1
Intervention: Flufirvitide 3
Conditions: Influenza
Sponsor: Autoimmune Technologies, LLC
Enrollment: 68
Locations: 1
Primary Endpoint: Change in adverse events from Baseline
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

February 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Autoimmune Technologies, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and non-pregnant, non-lactating female subjects of 18 to 50 years of age inclusive.
•Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive and body weight of 50 to 100 kg inclusive.
•Normal spirometry values at Screening and Baseline defined as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) greater than 80% predicted or above the LLN and the FEV1/FVC ratio greater than 70%. Results of FEV1 and FVC must be reproducible (± 5%) between Screening and Baseline.
•Post-menopausal women with amenorrhea for at least 2 years will be eligible (confirmed by follicle stimulating hormone \[FSH\] test).
•Females of childbearing potential must use acceptable birth control methods throughout the study and for 30 days after the last dose of the IMP:
•Male subjects:
•Must agree to use a condom (or diaphragm plus spermicide in female partner) from the time of the first dose of IMP through 90 days after the last dose.
•Must agree to not donate sperm for 90 days after the last dose of IMP.
•Vasectomies in males for 6 months minimum prior to the first dose of the IMP are an acceptable form of contraception.
•Males who claim abstinence as their method of contraception are allowed provided they agree to use a barrier method (diaphragm plus spermicide in female partner or condom) should they become sexually active from screening to 90 days after the last dose of IMP.