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

• ClinicalTrials.gov Identifier: NCT04982991
• Recruitment Status: Completed
• First Posted: July 29, 2021
• Last Update Posted: April 25, 2022
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis Healthy Subjects	Drug: RIPK1 inhibitor	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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 Name: SAR443820

Outcome Measures

Primary Outcome Measures :

1. Assessment of pharmacokinetic (PK) parameter: Cmax [ Time Frame: Up to day 3 ]
   Maximum plasma concentration
2. 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
3. Assessment of pharmacokinetic (PK) parameter: AUC [ Time Frame: Up to day 3 ]
   Area under the plasma concentration versus time curve

Secondary Outcome Measures :

1. Assessment of adverse events (AEs) [ Time Frame: Up to day 21 ]
   Number of participants with Adverse events

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United Kingdom

Investigational Site Number :8260001

Harrow, London, City Of, United Kingdom, HA1 3UJ

Sponsors and Collaborators

Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT04982991
• Other Study ID Numbers: PKM17247; 2021-001076-42 ( EudraCT Number ); U1111-1264-3008 ( Registry Identifier: ICTRP )
• First Posted: July 29, 2021
• Last Update Posted: April 25, 2022
• Last Verified: April 8, 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases