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Itepekimab AI

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |Sanofi|Last Updated: Sep 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Itepekimab AI · 1 trial · 1 indication

Phase 1 1
NCT06114238Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled SyringeChronic Obstructive Pulmonary Disease
COMPLETED90 Analytics
PHASE1COMPLETED
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax
Baseline up to EOS (approximately Day 141)

Maximum plasma concentration of itepekimab

Assessment of PK parameter of itepekimab: AUClast
Baseline up to EOS (approximately Day 141)

AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast

Assessment of PK parameter of itepekimab: AUC
Baseline up to EOS (approximately Day 141)

AUC: Area under the plasma concentration versus time curve extrapolated to infinity

Secondary Endpoints

Assessment of PK parameter of itepekimab: tmax
Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: AUC0-28days
Baseline up to Day 28
Assessment of PK parameter of itepekimab: t1/2
Baseline up to EOS (approximately Day 141)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALItepekimab administered via AI
Cohort 2ACTIVE_COMPARATORItepekimab administered via PFS

Interventions

NameTypeDescription
Itepekimab AIDRUGPharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI
Itepekimab PFSDRUGPharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: • Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: • Any participant who, in the judgment of the Investigator, is likely to be noncompli...

Countries:United States
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Frequently asked questions about Itepekimab AI

What is Itepekimab AI used for in Chronic Obstructive Pulmonary Disease?

Itepekimab AI is an investigational small molecule being developed for Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 1 clinical development, meaning it is still being studied and is not yet approved for use. The drug is being evaluated for its safety and pharmacokinetic profile in patients with COPD.

Who makes Itepekimab AI?

Itepekimab AI is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Chronic Obstructive Pulmonary Disease.

What phase is Itepekimab AI in?

Itepekimab AI is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetic properties in patients with Chronic Obstructive Pulmonary Disease.

What clinical trials is Itepekimab AI in?

Itepekimab AI has one completed Phase 1 clinical trial, identified as NCT06114238. This study was a pharmacokinetic comparison of Itepekimab administered via an autoinjector versus a prefilled syringe. The trial enrolled 90 participants in the United States and was active-controlled, though it was not double-blinded.

Is Itepekimab AI the same as Itepekimab?

Itepekimab AI is a small molecule formulation of Itepekimab, which is being developed by Sanofi. The 'AI' designation may refer to a specific formulation or delivery method. The drug is being studied for Chronic Obstructive Pulmonary Disease and is currently in Phase 1 clinical trials.