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AT-301B

Phase 1

Healthy | Small molecule | Other |Atossa Therapeutics, Inc.|Last Updated: Jan 19, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04519788AT-301 Nasal Spray in Healthy AdultsPHASE1 COMPLETED 32 — — Aug 7, 2020Jan 12, 2021Jan 19, 20211 Australia
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Study Endpoints
Primary Endpoints
cardiac, pulmonary and hemodynamic parameters using 12-lead ECG
from baseline through study completion, an average of 40 days

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

auscultation
from baseline through study completion, an average of 40 days

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

determination of oxygen saturation levels
from baseline through study completion, an average of 40 days

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

haematology, coagulation and serum chemistry
from baseline through study completion, an average of 40 days

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

urinalysis
from baseline through study completion, an average of 40 days

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

Secondary Endpoints
Nasal Spray Attributes Questionnaire score
from baseline through study completion, an average of 40 days
Incidence and severity of AE (bronchospasms)
from baseline through study completion, an average of 40 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AT-301BACTIVE_COMPARATORAT-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-301APLACEBO_COMPARATORAT-301A consists of sodium chloride, benzalkonium chloride and purified water (NaOH/HCl to adjust pH to 5.0)
Interventions
NameTypeDescription
AT-301BDRUGNasal Spray
AT-301ADRUGNasal Spray
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Australia
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