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ALX-0171

Phase 1

Healthy | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 10, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

ALX-0171 · 4 trials · 3 indications

Phase 1 4
NCT02309320A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171Respiratory Syncytial Virus Infection
COMPLETED53 Analytics
NCT01909843ALX-0171 Safety Study in Adults With Hyperresponsive AirwaysRespiratory Syncytial Virus Infection
COMPLETED24 Analytics
NCT01875926ALX-0171 Phase I Pharmacokinetic Study in Healthy Male VolunteersHealthy
COMPLETED44 Analytics
NCT01483911ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male VolunteersRSV Infection
COMPLETED60 Analytics
PHASE1COMPLETED
A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171
Respiratory Syncytial Virus Infection
NCT0230932053
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PHASE1COMPLETED
ALX-0171 Safety Study in Adults With Hyperresponsive Airways
Respiratory Syncytial Virus Infection
NCT0190984324
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PHASE1COMPLETED
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
Healthy
NCT0187592644
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PHASE1COMPLETED
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
RSV Infection
NCT0148391160
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Study Endpoints

Primary Endpoints

Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
1 day before first dose to 14 days after first dose
Number of subjects reacting with bronchoconstriction to treatment (ALX- 0171 placebo or ALX-0171 verum) with one or more drops in forced expiratory volume in one second (FEV1) within a period of 8h post-inhalation
Within a period of 8 hours post-inhalation
Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples
Day 1 to Day 9
Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration
Day 1 to Day 4
number of treatment-emergent adverse events
until 1 month after last study drug administration

Secondary Endpoints

Clinical activity as measured by the evaluation of the clinical response of the subjects
1 day before first dose to 14 days after first dose
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Day 3
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum
1 day before first dose to 14 days after first dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALX-0171EXPERIMENTALInhalation of ALX-0171 during 3 consecutive days
PlaceboPLACEBO_COMPARATORInhalation of Placebo during 3 consecutive days
ALX-0171 Oral inhalationEXPERIMENTAL -
ALX-0171 Oral Inhalation - Single Dose (SD)EXPERIMENTAL -
ALX-0171 Oral Inhalation - Multiple Dose (MD)EXPERIMENTAL -
ALX-0171 Intravenous (IV)EXPERIMENTAL -

Interventions

NameTypeDescription
ALX-0171BIOLOGICAL -
PlaceboOTHER -
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Eligibility Criteria

Age Range28 Days to 23 Months
SexALL
Healthy VolunteersNo
Study Sites59

Inclusion Criteria: 1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection) 2. Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV 3. Subject has a positive RSV diagnost...

Countries:AustraliaBelgiumBulgariaEstoniaHungaryIsraelLatviaMalaysiaPhilippinesPolandSlovakiaSpainThailandUnited KingdomGermanyNetherlands
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Frequently asked questions about ALX-0171

What is ALX-0171 used for?

ALX-0171 is an investigational monoclonal antibody being developed for respiratory syncytial virus (RSV) infection, including RSV lower respiratory tract infection. It has been studied in healthy volunteers and in infants and toddlers hospitalized with RSV lower respiratory tract infection.

What does ALX-0171 target?

ALX-0171 is a monoclonal antibody designed to target respiratory syncytial virus (RSV). It is being developed as a potential treatment for RSV infection and RSV lower respiratory tract infection.

Who makes ALX-0171?

ALX-0171 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY.

What phase is ALX-0171 in?

ALX-0171 has completed Phase 1 and Phase 2 clinical trials. It remains an investigational drug and is not approved by regulatory authorities. All listed trials for ALX-0171 have been completed.

What clinical trials is ALX-0171 in?

ALX-0171 has been studied in several completed trials, including NCT01483911 in healthy male volunteers, NCT01909843 in adults with hyperresponsive airways, NCT02309320 in infants and toddlers with RSV lower respiratory tract infection, and NCT02979431, a dose-ranging study in hospitalized infants.

Is ALX-0171 the same as other RSV treatments?

ALX-0171 is a distinct investigational monoclonal antibody targeting respiratory syncytial virus (RSV). It is not the same as other approved RSV treatments, as it remains in clinical development and has not received regulatory approval.