Back to results

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

Primary Purpose

Multiple Sclerosis Healthy Subjects

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

RIPK1 inhibitor

About this trial

This is an interventional treatment trial for Multiple Sclerosis Healthy Subjects

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Investigational Site Number :8260001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAR443820

Arm Description

Participants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods

Outcomes

Primary Outcome Measures

Assessment of pharmacokinetic (PK) parameter: Cmax

Maximum plasma concentration

Assessment of pharmacokinetic (PK) parameter: AUClast

Area under the plasma concentration versus time curve from time zero to the real time last

Assessment of pharmacokinetic (PK) parameter: AUC

Area under the plasma concentration versus time curve

Secondary Outcome Measures

Assessment of adverse events (AEs)

Number of participants with Adverse events

Full Information

NCT ID

NCT04982991

First Posted

July 20, 2021

Last Updated

April 21, 2022

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT04982991

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 8, 2022

Overall Recruitment Status

Completed

Study Start Date

August 5, 2021 (Actual)

Primary Completion Date

October 11, 2021 (Actual)

Study Completion Date

October 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis Healthy Subjects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR443820

Arm Type

Experimental

Arm Description

Participants will receive a single sequence of 3 different doses of SAR443820 in a total of 3 treatment periods

Intervention Type

Drug

Intervention Name(s)

RIPK1 inhibitor

Other Intervention Name(s)

SAR443820

Intervention Description

Capsule Oral

Primary Outcome Measure Information:

Title

Assessment of pharmacokinetic (PK) parameter: Cmax

Description

Maximum plasma concentration

Time Frame

Up to day 3

Title

Assessment of pharmacokinetic (PK) parameter: AUClast

Description

Area under the plasma concentration versus time curve from time zero to the real time last

Time Frame

Up to day 3

Title

Assessment of pharmacokinetic (PK) parameter: AUC

Description

Area under the plasma concentration versus time curve

Time Frame

Up to day 3

Secondary Outcome Measure Information:

Title

Assessment of adverse events (AEs)

Description

Number of participants with Adverse events

Time Frame

Up to day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Investigational Site Number :8260001

City

Harrow

State/Province

London, City Of

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

We'll reach out to this number within 24 hrs