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 being studied in healthy volunteers. It is being evaluated for safety and immunogenicity in clinical trials. NasoShield is not approved by the FDA and remains in clinical development.
NasoShield is being developed by Altimmune, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALT. The company is conducting clinical trials to evaluate the safety and immunogenicity of NasoShield in healthy adult volunteers.
NasoShield is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 188 participants enrolled. Both trials were randomized, double-blind, and placebo-controlled, and they evaluated the safety and immunogenicity of NasoShield in healthy volunteers.
NasoShield has been studied in two completed Phase 1 clinical trials. The first trial, NCT03352466, enrolled 145 healthy volunteers in the United States. The second trial, NCT04415749, enrolled 43 healthy adults in the United States. Both trials assessed safety and immunogenicity.
NasoShield is the proprietary name for the investigational monoclonal antibody developed by Altimmune, Inc. No alternative names for NasoShield have been disclosed in the clinical trial records. The drug is being studied under the name NasoShield in its clinical trials.