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NCT05795907 · ClinicalTrials.gov registry record · Phase 1
Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT05795907 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 84 participants.
The verdict
NCT05795907, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
This is a Phase 1, single-center study conducted in 2 parts: Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled sequential ascending single oral doses including up to 6 cohorts. Each cohort will include 8 participants (6 receiving SAR443820 and 2 placebo). Part 1b (TDU16519): - Open label, single SAR443820 dose in one or two separated cohort(s) for SAR443820 measurements in CSF and in plasma. Part 2, multiple ascending dose (MAD -TDR16520): Double-blind, randomized, placebo-controlled, sequential ascending repeated oral doses for 14 days, including up to 4 cohorts. Each cohort will include 10 participants (8 receiving SAR443820 and 2 placebo).
Interventions
- DRUG Placebo
- DRUG SAR443820
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2020-11-30 |
| Est. Completion | 2021-07-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05795907
The ClinicalTrials.gov registry entry for NCT05795907 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05795907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05795907 about?
NCT05795907 is a clinical study titled "Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants". This is a Phase 1, single-center study conducted in 2 parts: Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled sequential ascending single oral doses including up to 6 cohorts. Each cohort will include 8 participants (6 receiving SAR443820 and 2 placebo). ...
What is the current status of trial NCT05795907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2020-11-30. Estimated completion is 2021-07-20.
What interventions are being tested in trial NCT05795907?
The interventions under investigation include: Placebo (DRUG), SAR443820 (DRUG).
Who is sponsoring clinical trial NCT05795907?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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