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OpenTrials
Completed

NCT Number: NCT06326814

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

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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Key information

Conditions

Paroxysmal Nocturnal Hemoglobinuria Anemia Anemia, Hemolytic Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Myelodysplastic Syndromes

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International Site Number : 8400002, Glendale, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Humanized anti-Factor Bb monoclonal antibody

Drug

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

Other names: SAR443809

Placebo

Drug

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

Primary outcomes

  1. Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)

    Time frame: Baseline up to 23 weeks

  2. Incidence of potentially Clinical laboratory abnormalities

    Time frame: Baseline up to 23 weeks

Secondary outcomes

  1. PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax

    Time frame: Baseline up to 23 weeks

  2. PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax

    Time frame: Baseline up to 23 weeks

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F)

    Time frame: Baseline up to 23 weeks

  9. PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss)

    Time frame: Baseline up to 23 weeks

  10. PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F)

    Time frame: Baseline up to 23 weeks

  11. PK parameters of SAR443809 for SC administrations: absolute bioavailability (F)

    Time frame: Baseline up to 23 weeks

  12. 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)

  13. 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

  14. Incidence of treatment -emergent Anti-SAR443809 antibodies

    Time frame: Baseline up to 23 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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