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A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults

NCT ID: NCT06326814

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-11

Study Completion Date

2023-05-05

Brief Summary

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Primary objective

* The tolerability and safety of SAR443809 Secondary
* The PK parameters of SAR443809
* The PD activity of SAR443809
* The immunogenicity of SAR443809

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Detailed Description

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Screening: up to 56 days (Day -56 to Day -2). Treatment: 1 day (treatment on Day 1, study observation period from Day -1 to Day 3). Follow-up and end of study: 105 days after IMP administration (follow up visits from Day 5 to Day 78; End of study visit on Day 106). Total study duration for each participant: approximately 23 weeks.

Conditions

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Paroxysmal Nocturnal Hemoglobinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAR443809 and placebo dose 1 Arm

6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1

Group Type EXPERIMENTAL

Humanized anti-Factor Bb monoclonal antibody

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

SAR443809 and placebo dose 2 Arm

6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2

Group Type EXPERIMENTAL

Humanized anti-Factor Bb monoclonal antibody

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

SAR443809 and placebo dose 3 Arm

6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3

Group Type EXPERIMENTAL

Humanized anti-Factor Bb monoclonal antibody

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

SAR443809 and placebo dose 4 Arm

6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4

Group Type EXPERIMENTAL

Humanized anti-Factor Bb monoclonal antibody

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

SAR443809 and placebo dose 5 Arm

6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5

Group Type EXPERIMENTAL

Humanized anti-Factor Bb monoclonal antibody

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

SAR443809 and placebo dose 6 Arm

Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6

Group Type EXPERIMENTAL

Humanized anti-Factor Bb monoclonal antibody

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

SAR443809 and placebo dose 7 Arm

Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7

Group Type EXPERIMENTAL

Humanized anti-Factor Bb monoclonal antibody

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Placebo

Intervention Type DRUG

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Interventions

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Humanized anti-Factor Bb monoclonal antibody

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Intervention Type DRUG

Placebo

Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Intervention Type DRUG

Other Intervention Names

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SAR443809

Eligibility Criteria

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Inclusion Criteria

Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Parexel International Site Number : 8400002

Glendale, California, United States

Site Status

Parexel International Site Number : 8400003

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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U1111-1298-7281

Identifier Type: REGISTRY

Identifier Source: secondary_id

TDU16837

Identifier Type: -

Identifier Source: org_study_id

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