Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NasoShield · 2 trials · 1 indication
Subjects will record solicited local and systemic events for 7 days after each dose
All adverse events from Day 1 to Day 57; serious adverse events (SAE), medically attended adverse events (MAAE), and new-onset chronic illnesses (NCI) from Day 1 to Day 210
Subjects will record solicited local and systemic events for 14 days after each dose
All adverse events from Day 1 to Day 57, SAEs, medically attended AEs and new onset chronic illnesses Day 1 to Day 361
| Arm | Type | Description |
|---|---|---|
| NasoShield One Dose in Position 1 | EXPERIMENTAL | NasoShield (1 x 10\^11 vp) on Day 1 and saline placebo on Day 29 in position 1 (Group 1) in normal sitting position (no dose holding time) |
| Placebo in Position 1 | PLACEBO_COMPARATOR | Saline placebo on Day 1 and saline placebo on Day 29 in position 1 (Group 1) |
| NasoShield Two Doses in Position 2 | EXPERIMENTAL | NasoShield (1 x 10\^11 vp) on Day 1 and Day 29 in position 2 (Group 2) in sitting position with nostrils elevated above head for 3 minutes followed by sitting for 27 minutes |
| Placebo in Position 2 | PLACEBO_COMPARATOR | Saline placebo on Day 1 and Day 29 in position 2 (Group 2) |
| NasoShield Two Doses in Position 3 | EXPERIMENTAL | NasoShield (1 x 10\^11 vp) on Day 1 and Day 29 in position 3 (Group 3) in supine position for 30 minutes |
| Placebo in Position 3 | PLACEBO_COMPARATOR | Saline placebo on Day 1 and Day 29 in position 3 (Group 3) |
| NasoShield very low dose - 1 X 10^8 vp | EXPERIMENTAL | Single intranasal spray (Part A) |
| NasoShield low dose - 1 X 10^9 vp | EXPERIMENTAL | Single intranasal spray (Part A) |
| NasoShield medium dose - 1 X 10^10 vp | EXPERIMENTAL | Single intranasal spray (Part A) |
| NasoShield high dose - Part A -1 X 10^11 vp | EXPERIMENTAL | Single intranasal spray (Part A) |
| NasoShield high dose - Part B - 1 X 10^11 vp | EXPERIMENTAL | 2 intranasal sprays 21 days apart (Part B) |
| Placebo | PLACEBO_COMPARATOR | Normal saline, single intranasal spray (Part A) or two intranasal sprays 21 days apart (Part B) |
| BioThrax | ACTIVE_COMPARATOR | Three intramuscular injections 15 days apart (Part A) |
| Name | Type | Description |
|---|---|---|
| NasoShield | BIOLOGICAL | NasoShield is an adenovirus-vectored anthrax vaccine |
| Placebo | OTHER | Normal saline |
| BioThrax | BIOLOGICAL | Commercially available anthrax vaccine |
Inclusion Criteria: 1. Men and women 18 to 49 years of age, inclusive 2. Good general health status 3. Adequate venous access for repeated phlebotomies 4. Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Cre...
NasoShield is an investigational monoclonal antibody developed by Altimmune, Inc. It has been studied in Phase 1 clinical trials in healthy adult volunteers, with a focus on safety and immunogenicity. Both completed trials enrolled healthy volunteers aged 18 years and older in the United States.
NasoShield is developed by Altimmune, Inc., which trades on the Nasdaq under the ticker ALT. Altimmune is the sponsor of the clinical program for NasoShield, including the two completed Phase 1 trials conducted in the United States.
NasoShield is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The program has not been approved by the FDA and remains investigational. Across both completed studies, 188 participants were enrolled.
NasoShield has been evaluated in two completed Phase 1 trials: NCT04415749, which studied safety and immunogenicity in 43 healthy adults, and NCT03352466, a safety and immunogenicity study in 145 healthy adults. Both were conducted in the United States and enrolled participants aged 18 years and older.
Both NasoShield Phase 1 trials were randomized, double-blind, and placebo-controlled studies in healthy adult volunteers. NCT04415749 enrolled 43 participants and NCT03352466 enrolled 145, for a combined total of 188 participants. Both trials have been completed, and no NasoShield trials are currently active.