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Completed

NCT Number: NCT06159452

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

Up to 35 Days

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 any procedure related to the study. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
  • 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.

Treatment and study plan

SAR153191-P3 drug product

Drug

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

Other names: SAR153191

SAR153191-P2 drug product

Drug

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

Other names: SAR153191

SAR153191-C1F3 drug product

Drug

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

Other names: SAR153191

Primary outcomes

  1. Number of participants reporting injection site reactions

    Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21, and 35 following SAR153191 administration

    Injection site reactions include pain, erythema an edema.

Secondary outcomes

  1. Pharmacokinetics: Cmax

    Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration

    Maximum plasma concentration observed

  2. Pharmacokinetics: tmax

    Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration

    First time to reach Cmax

  3. Pharmacokinetics: AUClast

    Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration

    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time

  4. Pharmacokinetics: AUC

    Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration

    Area under the plasma concentration versus time curve extrapolated to infinity

  5. Pharmacokinetics: t1/2z

    Time frame: At predose and on Days 1, 2, 3, 4, 5, 7, 9, 11, 14, 21 and 35 following SAR153191 administration

    Terminal half-life associated with the terminal slope (λz)

  6. Safety: Number of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)

    Time frame: Up to 35 Days

  7. Incidence of anti-SAR153191 antibodies

    Time frame: At Day 1 predose and on Days 7, 21, and 35 (plus follow-up if positive)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Randomized, Double-blind, Single Subcutaneous Dose, Parallel Design 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 6, 2023
Registry last updated
Dec 6, 2023

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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