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ABT-308

Phase 1

Asthma | Small molecule | Respiratory |AbbVie Inc.|Last Updated: Nov 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

ABT-308 · 1 trial · 1 indication

Phase 1 1
NCT00986037Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With AsthmaAsthma
COMPLETED47 Analytics
PHASE1COMPLETED
Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments.
12 weeks after last dose

Secondary Endpoints

Pharmacokinetics will be determined by measuring serum concentration of ABT-308.
12 weeks after last dose
Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies.
12 weeks after last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IV ABT-308 in asthmaticsEXPERIMENTALABT-308 single escalating doses in mild to moderate asthmatics
SC ABT-308 in asthmaticsEXPERIMENTALABT-308 multiple SQ doses in mild to moderate asthmatics
IV ABT-308 in healthy volunteersEXPERIMENTALABT-308 single escalating IV doses in healthy volunteers

Interventions

NameTypeDescription
ABT-308DRUGSingle IV doses
PlaceboDRUGSingle IV dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy volunteers: 1. A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG. 2. BMI 18 to 29, inclusive. * Mild asthma patients: 1. Diagnosis of well-controlled, mild to moderate asthma by G...

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Frequently asked questions about ABT-308

What is ABT-308 used for?

ABT-308 is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it is still being studied and has not been approved for use.

Who makes ABT-308?

ABT-308 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is in Phase 1 clinical development for asthma.

What phase is ABT-308 in?

ABT-308 is in Phase 1 clinical development. It is an investigational drug for asthma and has not been approved by regulatory authorities. The drug is still being studied for safety and tolerability.

What clinical trials is ABT-308 in?

ABT-308 has one completed clinical trial, NCT00986037, titled 'Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma.' This Phase 1 study enrolled 47 participants and included healthy volunteers as well as subjects with asthma.

Is ABT-308 a small molecule?

Yes, ABT-308 is a small molecule drug. It is being developed as an oral or systemic treatment for asthma, though the specific route of administration has not been disclosed.