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AT-301B

Phase 1

Undisclosed | Small molecule | Other |Atossa Therapeutics, Inc.|Trials Updated: Jan 19, 2021

AT-301B development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

AT-301B clinical trials

AT-301B · 1 trial · 1 indication

Phase 1 1
NCT04519788AT-301 Nasal Spray in Healthy AdultsHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
AT-301 Nasal Spray in Healthy Adults
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about AT-301B

What is AT-301B?

AT-301B is an investigational small molecule being developed by Atossa Therapeutics, Inc. It is in Phase 1 clinical development. Atossa Therapeutics trades on the Nasdaq under the ticker ATOS. The specific disease indications for AT-301B have not been publicly disclosed.

Who makes AT-301B?

AT-301B is being developed by Atossa Therapeutics, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol ATOS. Atossa Therapeutics is the sponsor of the clinical program for AT-301B.

What phase is AT-301B in?

AT-301B is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial of AT-301B has been completed, and no active trials of AT-301B are currently listed.

What clinical trials is AT-301B in?

AT-301B has been studied in one completed Phase 1 trial, NCT04519788, titled AT-301 Nasal Spray in Healthy Adults. The trial enrolled 32 healthy adult volunteers in Australia, was randomized, double-blind, and placebo-controlled, and included participants aged 18 years and older.

Is AT-301B FDA approved?

No. AT-301B is an investigational drug in Phase 1 clinical development and is not FDA approved. Its only completed trial, NCT04519788, was a Phase 1 study in healthy adult volunteers conducted in Australia.