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

March 17, 2024 updated by: Sanofi

A First-in-human, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single Doses of SAR443809 in Healthy Adult Subjects

Primary objective

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Parexel International Site Number : 8400002
    • Maryland
      • Baltimore, Maryland, United States, 21255
        • Parexel International Site Number : 8400003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAR443809 and placebo dose 1 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 1
Drug: Humanized anti-Factor Bb monoclonal antibody
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Other Names:
  • SAR443809
Drug: Placebo
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Experimental: SAR443809 and placebo dose 2 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 2
Drug: Humanized anti-Factor Bb monoclonal antibody
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Other Names:
  • SAR443809
Drug: Placebo
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Experimental: SAR443809 and placebo dose 3 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 3
Drug: Humanized anti-Factor Bb monoclonal antibody
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Other Names:
  • SAR443809
Drug: Placebo
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Experimental: SAR443809 and placebo dose 4 Arm
6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 4
Drug: Humanized anti-Factor Bb monoclonal antibody
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Other Names:
  • SAR443809
Drug: Placebo
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Experimental: SAR443809 and placebo dose 5 Arm
6 participants receiving SAR443809 and 2 receiving placebo, subcutaneous administration dose 5
Drug: Humanized anti-Factor Bb monoclonal antibody
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Other Names:
  • SAR443809
Drug: Placebo
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Experimental: SAR443809 and placebo dose 6 Arm
Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 6
Drug: Humanized anti-Factor Bb monoclonal antibody
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Other Names:
  • SAR443809
Drug: Placebo
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Experimental: SAR443809 and placebo dose 7 Arm
Optional: 6 participants receiving SAR443809 and 2 receiving placebo, intravenous administration dose 7
Drug: Humanized anti-Factor Bb monoclonal antibody
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
Other Names:
  • SAR443809
Drug: Placebo
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
Incidence of potentially Clinical laboratory abnormalities
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
PK parameters of SAR443809 for SC administrations: absolute bioavailability (F)
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks
Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50])
Time Frame: Baseline up to 23 weeks
Ex vivo activity of the alternative pathway of complement in serum using the WIESLAB® Complement System Alternative Pathway kit and a hemolytic assay (AH50)
Baseline up to 23 weeks
Complement classical pathway activity (Wieslab CP)
Time Frame: Baseline up to 23 weeks
Ex vivo activity of the alternative pathway of complement in serum using the WIESLAB® Complement System Classical Pathway kit
Baseline up to 23 weeks
Incidence of treatment -emergent Anti-SAR443809 antibodies
Time Frame: Baseline up to 23 weeks
Baseline up to 23 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDU16837
  • U1111-1298-7281 (Other Identifier: WHO ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Paroxysmal Nocturnal Hemoglobinuria

Clinical Trials on Humanized anti-Factor Bb monoclonal antibody

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe