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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Treatments: Drug: Placebo; Drug: Humanized anti-Factor Bb monoclonal antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT06326814

U1111-1298-7281 (Other Identifier)

TDU16837

Details and patient eligibility

About

Primary objective

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

Full description

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Having given written informed consent prior to undertaking any study-related procedure Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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54 participants in 7 patient groups

SAR443809 and placebo dose 1 Arm

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Humanized anti-Factor Bb monoclonal antibody

SAR443809 and placebo dose 2 Arm

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Humanized anti-Factor Bb monoclonal antibody

SAR443809 and placebo dose 3 Arm

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Humanized anti-Factor Bb monoclonal antibody

SAR443809 and placebo dose 4 Arm

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Humanized anti-Factor Bb monoclonal antibody

SAR443809 and placebo dose 5 Arm

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Humanized anti-Factor Bb monoclonal antibody

SAR443809 and placebo dose 6 Arm

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Humanized anti-Factor Bb monoclonal antibody

SAR443809 and placebo dose 7 Arm

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Humanized anti-Factor Bb monoclonal antibody