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NCT05846009 · ClinicalTrials.gov registry record · Phase 1

A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects

A Phase 1 study, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
76
Enrollment target

NCT05846009: Completed Phase 1 study, sponsored by Sanofi.

NCT05846009 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05846009, a Phase 1 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
76 participants
Enrollment target

Study Summary

The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.

Interventions

  • DRUG Placebo
  • DRUG SAR442501

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2020-11-18
Est. Completion 2022-01-12
Phase Phase 1
Sanofi

713 total trials

What the finished NCT05846009 record still lists

NCT05846009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05846009 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05846009 about?

NCT05846009 is a clinical study titled "A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects". The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.

What is the current status of trial NCT05846009?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2020-11-18. Estimated completion is 2022-01-12.

What interventions are being tested in trial NCT05846009?

The interventions under investigation include: Placebo (DRUG), SAR442501 (DRUG).

Who is sponsoring clinical trial NCT05846009?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05846009's enrollment target sits among peer trials

76 705th of 2000 higher than 1,290 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05846009, the US trial registry maintained by the National Library of Medicine. NCT05846009 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.