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Amlitelimab DP1

Phase 1

Healthy Volunteers | Small molecule | Other |Sanofi|Last Updated: Sep 19, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05796479A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy ParticipantsPHASE1 COMPLETED 32 — — Apr 28, 2022May 22, 2023Sep 19, 20251 United States
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Study Endpoints
Primary Endpoints
Part 1: Maximum Plasma concentration observed (Cmax )
From Day1 up to Day92 (end of study [EOS])

Cmax after administration of a single SC dose of amlitelimab DP 1

Part 1: Area under the curve from the time of dosing to the last measurable concentration (AUClast)
From Day1 up to Day92 (EOS)

AUClast after administration of a single SC dose of amlitelimab DP 1

Part 1: Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
From Day1 up to Day92 (EOS)

AUC after administration of a single SC dose of amlitelimab DP 1

Part 2: Cmax of two different amlitelimab DPs (DP1 and DP2)
From Day1 up to Day92 (EOS)

Cmax after administration of a single SC dose of amlitelimab DP 1 and DP2

Part 2: AUClast of two different amlitelimab DPs (DP1 and DP2)
From Day1 up to Day92 (EOS)

AUClast after administration of a single SC dose of amlitelimab DP1 and DP 2

Part 2: AUC of two different amlitelimab DPs (DP1 and DP2)
From Day1 up to Day92 (EOS)

AUC after administration of a single SC dose of amlitelimab DP1 and DP 2

Secondary Endpoints
Part 1 and Part 2: Incidence of adverse events (AE)/treatment-emergent adverse events (TEAEs)
From the signing of the informed consent form (ICF) up to Day92 EOS visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Group 1 (Part1)EXPERIMENTALParticipants will receive a single SC dose of amlitelimab DP1 on Day 1.
Group 2 (Part 2)EXPERIMENTALParticipants will receive a single SC dose of amlitelimab DP1 on Day 1.
Group 3 (Part 2)EXPERIMENTALParticipants will receive a single SC dose of amlitelimab DP2 on Day 1.
Interventions
NameTypeDescription
Amlitelimab DP1DRUGInjection solution 1 Subcutaneous
Amlitelimab DP2DRUGInjection solution 2 Subcutaneous
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, and laboratory tests * Body weight within 55 to 10...

Countries:United States
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