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Study of the Tolerability of Different SAR153191 Drug Products, That Differ With Respect to Manufacturing Processes and Formulation, at Different Concentrations and Doses in Healthy Male Subjects

NCT06159452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-12-06

No results posted yet for this study

Summary

Primary objective:

To determine the tolerability of different SAR153191 drug products that differ with respect to manufacturing processes and formulation, at different concentrations and doses, after administration of single subcutaneous doses to healthy male subjects.

Secondary objectives:

To determine the pharmacokinetic profile of the different SAR153191 drug products administered subcutaneously.

To assess the safety of the different SAR153191 drug products administered subcutaneously.

Conditions

Interventions

DRUG

SAR153191-P3 drug product

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

DRUG

SAR153191-P2 drug product

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

DRUG

SAR153191-C1F3 drug product

Pharmaceutical form:Solution for injection-Route of administration:Subcutaneous injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-09
Primary Completion
2010-12-21
Completion
2010-12-21
FDA Drug
Yes

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Entities

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 NCT06159452 on ClinicalTrials.gov