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

Paroxysmal Nocturnal Hemoglobinuria Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06326814
• Other study ID #: TDU16837
• Secondary ID: U1111-1298-7281
• Status: Completed
• Phase: Phase 1
• Start date: October 11, 2021
• Est. completion date: May 5, 2023

Study information

• Verified date: March 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary objective

• The tolerability and safety of SAR443809 Secondary

• The PK parameters of SAR443809

• The PD activity of SAR443809

• The immunogenicity of SAR443809

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemoglobinuria
• Hemoglobinuria, Paroxysmal
• Paroxysmal Nocturnal Hemoglobinuria

Intervention

Drug:
• Humanized anti-Factor Bb monoclonal antibody
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration
• Placebo
Pharmaceutical form:Solution for injection-Route of administration:IV and SC routes of administration

Locations

Country	Name	City	State
United States	Parexel International Site Number : 8400003	Baltimore	Maryland
United States	Parexel International Site Number : 8400002	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)		Baseline up to 23 weeks
Primary	Incidence of potentially Clinical laboratory abnormalities		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax		Baseline up to 23 weeks
Secondary	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)		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-8)		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (?z) (t1/2z)		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast)		Baseline up to 23 weeks
Secondary	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)		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F)		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss)		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F)		Baseline up to 23 weeks
Secondary	PK parameters of SAR443809 for SC administrations: absolute bioavailability (F)		Baseline up to 23 weeks
Secondary	Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50])	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
Secondary	Complement classical pathway activity (Wieslab CP)	Ex vivo activity of the alternative pathway of complement in serum using the WIESLAB® Complement System Classical Pathway kit	Baseline up to 23 weeks
Secondary	Incidence of treatment -emergent Anti-SAR443809 antibodies		Baseline up to 23 weeks