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ALX-0171

Phase 1

Healthy | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jul 13, 2018

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01875926ALX-0171 Phase I Pharmacokinetic Study in Healthy Male VolunteersPHASE1 COMPLETED 44May 1, 2013Oct 1, 2013Jul 13, 20181 Belgium
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Study Endpoints
Primary Endpoints
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
Secondary Endpoints
Safety and tolerability: safety markers
from signing of Informed Consent Form (ICF) until last follow-up visit (i.e 35 to 42 days after first study drug administration)
Immunogenicity: concentration of Anti-Drug Antibodies (ADA)in induced sputum (after oral inhalation only) and serum
during screening until last follow-up visit (i.e. 35 to 42 days after first study drug administration)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALX-0171 Oral Inhalation - Single Dose (SD)EXPERIMENTAL -
ALX-0171 Oral Inhalation - Multiple Dose (MD)EXPERIMENTAL -
ALX-0171 Intravenous (IV)EXPERIMENTAL -
Interventions
NameTypeDescription
ALX-0171BIOLOGICALsingle dose of 200 mg ALX-0171 via oral inhalation
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Non-smoking healthy male volunteers, (18-55 years, extremes included). 2. Good health condition, as determined by medical history, physical examination and clinical laboratory testing 3. Body mass index (BMI) within normal range: 18.0 ≤ BMI \< 30.0 (kg/m2) 4. Haematology and ...

Countries:Belgium
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