Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05845996
• Other study ID #: TDU15525-TDR15526
• Secondary ID: U1111-1217-2909
• Status: Completed
• Phase: Phase 1
• Start date: November 8, 2018
• Est. completion date: April 10, 2020

Study information

• Verified date: September 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344

Description:

The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 10, 2020
• Est. primary completion date: April 10, 2020
• 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

• Any subject 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

• Healthy Volunteers

Intervention

Drug:
• SAR441344
Solution for intravenous/subcutaneous injection
• placebo
Solution for intravenous/subcutaneous injection

Biological:
• Keyhole limpet hemocyanin
Subcutaneous Lyophilized powder for reconstitution

Locations

Country	Name	City	State
United States	PPD-Site Number:8400001	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of participants with adverse event(AE)	Number of participants with AE from baseline to day 127	From baseline to day 127
Primary	Part 2: Number of participants with adverse event (AE)	Number of participants with AE from baseline to day 155	From baseline to day 155
Secondary	Assessment of PK parameter: Cmax	Maximum plasma concentration (Cmax) observed	From Day 1 to Day 127 and to Day 155
Secondary	Assessment of PK parameter: tmax	First time to reach Cmax (tmax)	From Day 1 to Day 127 and Day 155
Secondary	Assessment of PK parameter: AUClast	Area under the plasma concentration versus time curve from time zero to the real time	From Day 1 to Day 127
Secondary	Assessment of PK parameter: AUC	From Day 1 to Day 127	Area under the plasma concentration versus time curve extrapolated to infinity
Secondary	Assessment of PK parameter: AUC0-tau	Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours)	From day 1 to Day 155
Secondary	Assessment of PK parameter: Ctrough	Plasma concentration observed just before treatment administration during repeated dosing	From Day 1 to Day 155
Secondary	Assessment of PK parameter: t1/2z	Terminal half-life associated with the terminal slope (?z)	From Day 1 to Day 127 and Day 155
Secondary	Assessment of PK parameter: CL(/F)	From Day 1 to Day 127	Apparent total body clearance of a drug from the plasma
Secondary	Assessment of PK parameter: CLss(/F)	From day 1 to Day 155	Apparent total body clearance of a drug from the plasma
Secondary	Anti-SAR441344 antibodies	Number of subjects with treatment emergent anti-drug antibody formation	From Day 1 to Day 127 and Day 155
Secondary	Assessment of anti-KLH IgG and IgM	Measurement of anti-KLH IgG and IgM levels in response to KLH immunization	From Day 1 to Day 127 and Day 155
Secondary	AE attributed to KLH immunization	Number of participants with AE attributed to KLH immunization	From Day 1 to Day 127 and Day 155