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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flufirvitide-3 dose level 1 | Experimental | Single dose administration for dose level 1 |
|
| Flufirvitide 3-Dose level 2 | Experimental | Single dose administration for Dose Level 2 |
|
| Placebo | Placebo Comparator | Single Dose administration Placebo for Flufirvitide-3 |
|
| Flufirvitide-3 Dose level 1- Repeat dose | Experimental | Repeat dose administration for five days |
|
| Flufirvitide-3-Dose level 2 Repeat dose | Experimental | Repeat dose administration for 5 days |
|
| Placebo for Flufirvitide-3 Repeat dose | Placebo Comparator | Repeat dose administration for 5 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flufirvitide 3 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in adverse events from Baseline | 8 days |
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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:
Willing and able to provide written informed consent and provide authorization for use of protected health information (HIPAA).
Willing and able to adhere to the lifestyle guideline restrictions outlined in the protocol.
Willing and able to be confined to the CRU as required by the protocol.
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo for Flufirvitide-3 | Drug |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |