Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AT-301B · 1 trial · 1 indication
incidence of abnormal ECG Change from baseline in clinical laboratory parameters * Change from baseline in vital signs parameters * Change from baseline in 12-lead ECGs * Change from baseline in physical examination findings including auscultation * Change from baseline in oxygen saturation
incidence of abnormal sounds Change from baseline in clinical laboratory parameters * Change from baseline in vital signs parameters * Change from baseline in 12-lead ECGs * Change from baseline in physical examination findings including auscultation * Change from baseline in oxygen saturation
Incidence of abnormal oxygen saturation Change from baseline in clinical laboratory parameters * Change from baseline in vital signs parameters * Change from baseline in 12-lead ECGs * Change from baseline in physical examination findings including auscultation * Change from baseline in oxygen saturation
incidence of abnormal ranges Change from baseline in clinical laboratory parameters * Change from baseline in vital signs parameters * Change from baseline in 12-lead ECGs * Change from baseline in physical examination findings including auscultation * Change from baseline in oxygen saturation
incidence of abnormal measures Change from baseline in clinical laboratory parameters * Change from baseline in vital signs parameters * Change from baseline in 12-lead ECGs * Change from baseline in physical examination findings including auscultation * Change from baseline in oxygen saturation
| Arm | Type | Description |
|---|---|---|
| AT-301B | ACTIVE_COMPARATOR | AT-301B consists of edetate disodium, glyceryl monooleate, polysorbate 80, benzalkonium chloride, microcrystalline cellulose and sodium carboxymethylcellulose (vivapur), trisodium citrate dihydrate, and purified water (HCl to adjust pH to 5.0) |
| AT-301A | PLACEBO_COMPARATOR | AT-301A consists of sodium chloride, benzalkonium chloride and purified water (NaOH/HCl to adjust pH to 5.0) |
| Name | Type | Description |
|---|---|---|
| AT-301B | DRUG | Nasal Spray |
| AT-301A | DRUG | Nasal Spray |
Inclusion Criteria: Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects 2. Adult males and females, 18 to 64 years of age (inclusive) at the...
AT-301B is an investigational small molecule being developed by Atossa Therapeutics, Inc. (NASDAQ: ATOS). It is formulated as a nasal spray and is being studied in healthy adults. The drug is currently in Phase 1 clinical development, with one completed trial evaluating its safety and tolerability.
AT-301B is being studied for use in healthy individuals as a preventive or prophylactic measure, though its specific intended indication has not been disclosed. The Phase 1 trial enrolled healthy adult volunteers to assess the drug's safety and tolerability when administered as a nasal spray.
AT-301B is being developed by Atossa Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ATOS. The company is conducting clinical research on this investigational nasal spray formulation.
AT-301B is in Phase 1 clinical development. A Phase 1 trial has been completed, but the drug remains investigational and has not been approved by regulatory authorities. Further clinical studies would be needed to establish its safety and efficacy.
AT-301B has one completed Phase 1 clinical trial, identified as NCT04519788, titled "AT-301 Nasal Spray in Healthy Adults." This randomized, double-blind, placebo-controlled study enrolled 32 healthy participants in Australia and evaluated the drug's safety and tolerability.
AT-301B is a variant or formulation of AT-301, as indicated by the clinical trial title "AT-301 Nasal Spray in Healthy Adults." The drug is being developed by Atossa Therapeutics under the AT-301 program, with AT-301B representing a specific version of the compound.