Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR443820 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Part-A, Period-1 | EXPERIMENTAL | Single dose of SAR443820 tablet on Day 1 |
| Part-A, Period-2 | EXPERIMENTAL | Single dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9 |
| Part-B, Period-1 | EXPERIMENTAL | Single dose of SAR443820 capsule on Day 1 |
| Part-B, Period-2 | EXPERIMENTAL | Single dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11 |
| Treatment A | EXPERIMENTAL | Single dose of SAR443820 tablet in fasted condition |
| Treatment B | EXPERIMENTAL | Single dose of SAR443820 capsule in fasted condition |
| Treatment C | EXPERIMENTAL | Single dose of SAR443820 tablet in fasted condition |
| Treatment D | EXPERIMENTAL | Single dose of SAR443820 tablet in fed condition |
| SAR443820 | EXPERIMENTAL | Single dose oral ascending dose (parts 1a and 1b) and multiple ascending oral dose (part 2) of SAR443820 |
| Placebo | PLACEBO_COMPARATOR | Single dose oral ascending dose (part 1a) and multiple ascending oral dose (part 2) of matching placebo |
| Name | Type | Description |
|---|---|---|
| SAR443820 | DRUG | Tablet by oral administration |
| Erythromycin ethyl succinate | DRUG | Tablet by oral administration |
| Itraconazole | DRUG | Capsule by oral administration |
| Placebo | DRUG | Matching Capsule / Oral |
Inclusion Criteria: * Part A: male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Part B: male participant only must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Body weight between 50.0 and 100.0 kg,...
SAR443820 is an investigational small molecule being developed for amyotrophic lateral sclerosis (ALS). It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. SAR443820 is not yet approved and remains under clinical investigation.
SAR443820 is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is conducting Phase 1 clinical trials of SAR443820 in the United States.
SAR443820 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for SAR443820 are Phase 1 studies, and the drug remains in early-stage clinical testing.
SAR443820 has completed two Phase 1 trials: NCT05795907, a single and multiple ascending dose study in healthy adults, and NCT05797701, a study assessing absorption of the tablet versus capsule formulation. A third trial, NCT05797753, evaluated drug interactions with erythromycin and itraconazole.
SAR443820 is the investigational code name for this drug candidate. No alternative names have been disclosed in the available clinical trial information. The drug is identified solely as SAR443820 in the studies registered on ClinicalTrials.gov.