Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SAR443820

Placebo

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (Healthy Volunteers)

Eligibility Criteria

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

Inclusion Criteria: Male and/or female participant, between 18 and 55 years of age, inclusive. Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). Having given written informed consent prior to undertaking any study-related procedure. Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. Exclusion Criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. Personal medical history of seizure. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). 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, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Positive result for hepatitis B, C or HIV Positive result on urine drug screen Positive alcohol test. Any consumption of citrus fruits or their juices within 5 days before inclusion. Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C-SSRS), or a lifetime suicide attempt. Additional exclusion criteria applied, and specially for Part 1b, criteria related to the study procedure of lumbar puncture. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Prism Research-Site Number:8400001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR443820

Placebo

Arm Description

Single dose oral ascending dose (parts 1a and 1b) and multiple ascending oral dose (part 2) of SAR443820

Single dose oral ascending dose (part 1a) and multiple ascending oral dose (part 2) of matching placebo

Outcomes

Primary Outcome Measures

Parts 1a and 1b: Number of participants with adverse events

Part 2: Number of participants with adverse events

Secondary Outcome Measures

Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma

Parts 1a and 1b: Maximum plasma concentration

Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma

Parts 1a and 1b: time to reach Cmax

Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: AUC in plasma

Parts 1a and 1b: Area under the plasma concentration versus time

Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma

Terminal half-life in plasma

Part1b: SAR443820 concentrations in cerebrospinal fluid (CSF) samples

Part 1b: CSF to plasma concentration ratio

Part 2: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma

Part 2: Maximum plasma concentration

Part 2: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma

Part 2: Time to reach Cmax

Part 2: Assessment of pharmacokinetic parameter of SAR443820: AUC tau in plasma

Part 2: Area under the plasma concentration versus time during a dosing interval

Part 2 Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma

Terminal half-life in plasma

Part 2: Day14/Day1 of 4β-hydroxycholesterol ratio in plasma

D14/D1 of 4β-hydroxycholesterol ratio

Full Information

NCT ID

NCT05795907

First Posted

March 8, 2023

Last Updated

March 21, 2023

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT05795907

Brief Title

Single & Multiple Ascending Dose Study of SAR443820 in Healthy Adult Participants

Official Title

A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of SAR443820 in Healthy Adult Participants.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

November 30, 2020 (Actual)

Primary Completion Date

July 20, 2021 (Actual)

Study Completion Date

July 20, 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

Yes

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

This is a Phase 1, single-center study conducted in 2 parts: Part 1a, single ascending dose (SAD-TDU16519): Double-blind, randomized, placebo-controlled sequential ascending single oral doses including up to 6 cohorts. Each cohort will include 8 participants (6 receiving SAR443820 and 2 placebo). Part 1b (TDU16519): - Open label, single SAR443820 dose in one or two separated cohort(s) for SAR443820 measurements in CSF and in plasma. Part 2, multiple ascending dose (MAD -TDR16520): Double-blind, randomized, placebo-controlled, sequential ascending repeated oral doses for 14 days, including up to 4 cohorts. Each cohort will include 10 participants (8 receiving SAR443820 and 2 placebo).

Detailed Description

The duration of the study for a participant will include: Screening Period: up to 28 days Part 1a: Treatment in fasted condition: 1 day (Day 1). Study observation Period from Day -2/Day -1 to Day 3. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening per participant: up to 5 weeks. Part 1b: Treatment in fed condition: 1 day (Day 1). Study observation Period from Day -1/Day1 to Day 2. Follow-up with the end of study: from Day 5 to Day 7. Total duration from screening per participant: up to 5 weeks. Part 2: Treatment: 14 days (Day 1 to Day 14). Study observation Period from Day -2/Day -1 to Day 17. Follow-up with the end of study: from Day 19 to Day 21. Total duration from screening per participant: up to 7 weeks.

6. Conditions and Keywords

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

Amyotrophic Lateral Sclerosis (Healthy Volunteers)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Part 1b with open label study design

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR443820

Arm Type

Experimental

Arm Description

Single dose oral ascending dose (parts 1a and 1b) and multiple ascending oral dose (part 2) of SAR443820

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Single dose oral ascending dose (part 1a) and multiple ascending oral dose (part 2) of matching placebo

Intervention Type

Drug

Intervention Name(s)

SAR443820

Intervention Description

Capsule / Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Capsule / Oral

Primary Outcome Measure Information:

Title

Parts 1a and 1b: Number of participants with adverse events

Time Frame

Day1 up to Day 7 (end of study visit)

Title

Part 2: Number of participants with adverse events

Time Frame

Day1 up to Day 21 (end of study visit)

Secondary Outcome Measure Information:

Title

Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma

Description

Parts 1a and 1b: Maximum plasma concentration

Time Frame

Day1

Title

Parts 1a and 1b: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma

Description

Parts 1a and 1b: time to reach Cmax

Time Frame

Day 1

Title

Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: AUC in plasma

Description

Parts 1a and 1b: Area under the plasma concentration versus time

Time Frame

Day1

Title

Parts 1a and 1b : Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma

Description

Terminal half-life in plasma

Time Frame

Day1

Title

Part1b: SAR443820 concentrations in cerebrospinal fluid (CSF) samples

Description

Part 1b: CSF to plasma concentration ratio

Time Frame

Day1

Title

Part 2: Assessment of pharmacokinetic parameter of SAR443820: Cmax in plasma

Description

Part 2: Maximum plasma concentration

Time Frame

Day1 and Day14

Title

Part 2: Assessment of pharmacokinetic parameter of SAR443820: tmax in plasma

Description

Part 2: Time to reach Cmax

Time Frame

Day1 and Day14

Title

Part 2: Assessment of pharmacokinetic parameter of SAR443820: AUC tau in plasma

Description

Part 2: Area under the plasma concentration versus time during a dosing interval

Time Frame

Day1 and Day14

Title

Part 2 Assessment of pharmacokinetic parameter of SAR443820: t1/2z in plasma

Description

Terminal half-life in plasma

Time Frame

Day14

Title

Part 2: Day14/Day1 of 4β-hydroxycholesterol ratio in plasma

Description

D14/D1 of 4β-hydroxycholesterol ratio

Time Frame

Day1 and Day14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and/or female participant, between 18 and 55 years of age, inclusive. Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). Having given written informed consent prior to undertaking any study-related procedure. Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. Exclusion Criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteo-muscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. Personal medical history of seizure. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). 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, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Positive result for hepatitis B, C or HIV Positive result on urine drug screen Positive alcohol test. Any consumption of citrus fruits or their juices within 5 days before inclusion. Current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C-SSRS), or a lifetime suicide attempt. Additional exclusion criteria applied, and specially for Part 1b, criteria related to the study procedure of lumbar puncture. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trial Transparency email recommended (Toll free for US & Canada)

Organizational Affiliation

Sanofi

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Prism Research-Site Number:8400001

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55144

Country

United States

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

Amyotrophic Lateral Sclerosis (Healthy Volunteers)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial