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

NCT06326814 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-03-22

No results posted yet for this study

Summary

Primary objective

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

Conditions

Interventions

DRUG

Humanized anti-Factor Bb monoclonal antibody

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

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2023-05-05
Completion
2023-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06326814 on ClinicalTrials.gov