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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT04982991
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
2.2
Actual Duration (Months)
6.4
Patients Per Site Per Month

Study Details

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
  • 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
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 :
Aug 5, 2021
Actual Primary Completion Date :
Oct 11, 2021
Actual Study Completion Date :
Oct 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 Names:
  • SAR443820

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of pharmacokinetic (PK) parameter: Cmax [Up to day 3]

      Maximum plasma concentration

    2. Assessment of pharmacokinetic (PK) parameter: AUClast [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 [Up to day 3]

      Area under the plasma concentration versus time curve

    Secondary Outcome Measures

    1. Assessment of adverse events (AEs) [Up to day 21]

      Number of participants with Adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Site City State Country Postal Code
    1 Investigational Site Number :8260001 Harrow London, City Of United Kingdom HA1 3UJ

    Sponsors and Collaborators

    • Sanofi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04982991
    Other Study ID Numbers:
    • PKM17247
    • 2021-001076-42
    • U1111-1264-3008
    First Posted:
    Jul 29, 2021
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 8, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis

    Study Results

    No Results Posted as of Apr 25, 2022