Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants
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|ClinicalTrials.gov Identifier: NCT04982991|
Recruitment Status : Completed
First Posted : July 29, 2021
Last Update Posted : April 25, 2022
To assess the pharmacokinetic parameters of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants.
To assess the tolerability and safety of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Healthy Subjects||Drug: RIPK1 inhibitor||Phase 1|
The duration of the study for a participant will be up to approximately 7 weeks and include:
- Screening period: up to 4 weeks (Day -28 to Day -2).
- Institutionalization period at each period of treatment: 4 days (Day -1 to Day 3, single SAR443820 administration on Day 1).
- Wash-out period: at least 5 days between each dosing.
- End-of-study visit: Period 3/ Day 6±1 day.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, 3-treatment Period, 1-sequence, Cross-over Study of the Pharmacokinetics, Safety and Tolerability After Single Ascending Oral Doses of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants.|
|Actual Study Start Date :||August 5, 2021|
|Actual Primary Completion Date :||October 11, 2021|
|Actual Study Completion Date :||October 11, 2021|
Participants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods
Drug: RIPK1 inhibitor
Other Name: SAR443820
- Assessment of pharmacokinetic (PK) parameter: Cmax [ Time Frame: Up to day 3 ]Maximum plasma concentration
- Assessment of pharmacokinetic (PK) parameter: AUClast [ Time Frame: Up to day 3 ]Area under the plasma concentration versus time curve from time zero to the real time last
- Assessment of pharmacokinetic (PK) parameter: AUC [ Time Frame: Up to day 3 ]Area under the plasma concentration versus time curve
- Assessment of adverse events (AEs) [ Time Frame: Up to day 21 ]Number of participants with Adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982991
|Investigational Site Number :8260001|
|Harrow, London, City Of, United Kingdom, HA1 3UJ|