Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants

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.

Primary Objective:

To assess the pharmacokinetic parameters of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants.

Secondary Objective:

To assess the tolerability and safety of SAR443820 after ascending single oral doses in healthy East Asian (Chinese and Japanese) adult participants

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis Healthy Subjects
• Intervention / Treatment: Drug: RIPK1 inhibitor

Detailed Description

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
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, City Of
    • Harrow, London, City Of, United Kingdom, HA1 3UJ
      • Investigational Site Number :8260001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

East Asian (Chinese and Japanese) male and/or female participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent.

Chinese or Japanese ethnicity, according to the following criteria:

Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China.

Japanese; born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.

Body weight within 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, and body mass index (BMI) within the range 18.0 and 30.0 kg/m2, inclusive.

Exclusion Criteria:

Medical history of any seizure.

Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any live attenuated vaccine given within 3 months or any non-live vaccine given within 2 weeks before inclusion, and any biologics (antibody or its derivatives) given within 4 months before inclusion.

Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test.

Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the Columbia-Suicide Severity Rating Scale [C-SSRS]), or a lifetime suicide attempt. A "yes" response to questions 4 or 5 on the Suicidal Ideation section, or a score of 4 or 5 on the Intensity of Ideation section of the baseline/screening version of the C-SSRS at screening, or on the Since Last Visit version of the C-SSRS at baseline.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAR443820; Participants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods	Drug: RIPK1 inhibitor; Capsule Oral; Other Names: SAR443820

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pharmacokinetic (PK) parameter: Cmax	Maximum plasma concentration	Up to day 3
Assessment of pharmacokinetic (PK) parameter: AUClast	Area under the plasma concentration versus time curve from time zero to the real time last	Up to day 3
Assessment of pharmacokinetic (PK) parameter: AUC	Area under the plasma concentration versus time curve	Up to day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of adverse events (AEs)	Number of participants with Adverse events	Up to day 21

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): October 11, 2021
• Study Completion (Actual): October 11, 2021

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 8, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: PKM17247; 2021-001076-42 (EudraCT Number); U1111-1264-3008 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No