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SAR442501

Phase 1

Osteochondrodysplasia | Small molecule | Rare Disease |Sanofi|Last Updated: Aug 27, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

SAR442501 · 1 trial · 1 indication

Phase 1 1
NCT05846009A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults SubjectsOsteochondrodysplasia
COMPLETED76 Analytics
PHASE1COMPLETED
A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
Osteochondrodysplasia
NCT0584600976
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Study Endpoints

Primary Endpoints

Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
Baseline up to end of study (EOS) (Day 89)

Secondary Endpoints

Assessment of PK parameter: Maximum observed concentration (Cmax)
Baseline up to EOS (Day 89)
Assessment of PK parameter: First time to reach Cmax (tmax)
Baseline up to EOS (Day 89)
Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)
Baseline up to EOS (Day 89)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR442501EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SAR442501DRUGSubcutaneous injection
PlaceboDRUGSubcutaneous injection
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants, between 18 and 45 years of age, inclusive. * Body weight between 50.0 and 85.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive. * Certified as healthy by a comprehensive clinical assessment. * Having given written informed co...

Countries:United States
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Frequently asked questions about SAR442501

What is SAR442501 used for?

SAR442501 is an investigational small molecule being developed by Sanofi for the treatment of osteochondrodysplasia, a group of rare genetic disorders affecting bone and cartilage development. It is currently in Phase 1 clinical development.

Who makes SAR442501?

SAR442501 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is in Phase 1 clinical development for osteochondrodysplasia.

What phase is SAR442501 in?

SAR442501 is in Phase 1 clinical development. It has completed a first-in-human study in healthy adults, and it remains an investigational drug that has not been approved by regulatory authorities.

What clinical trials is SAR442501 in?

SAR442501 has one completed Phase 1 clinical trial, identified as NCT05846009. This was a first-in-human, single and repeated dose escalation study conducted in healthy adult subjects in the United States, with a total enrollment of 76 participants.

Is SAR442501 being tested in healthy volunteers?

Yes, SAR442501 has been studied in healthy adult volunteers. The completed Phase 1 trial, NCT05846009, enrolled healthy adults aged 18 years and older in the United States to evaluate the safety and tolerability of the drug.