NCT06159452

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2010

Completed
12.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 28, 2023

Last Update Submit

November 28, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of participants reporting injection site reactions

    Injection site reactions include pain, erythema an edema.

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

Secondary Outcomes (7)

  • Pharmacokinetics: Cmax

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

  • Pharmacokinetics: tmax

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

  • Pharmacokinetics: AUClast

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

  • Pharmacokinetics: AUC

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

  • Pharmacokinetics: t1/2z

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

  • +2 more secondary outcomes

Study Arms (7)

Group A

EXPERIMENTAL

SAR153191 - P3 drug product concentration 1 dose 1

Drug: SAR153191-P3 drug product

Group B

EXPERIMENTAL

SAR153191 - P2 drug product concentration 2 dose 2

Drug: SAR153191-P2 drug product

Group C

EXPERIMENTAL

SAR153191 - P3 drug product concentration 2 dose 2

Drug: SAR153191-P3 drug product

Group D

EXPERIMENTAL

SAR153191 - P3 drug product concentration 3 dose 3

Drug: SAR153191-P3 drug product

Group B'

EXPERIMENTAL

SAR153191 - P2 drug product concentration 2 dose 3

Drug: SAR153191-P2 drug product

Group C'

EXPERIMENTAL

SAR153191 - P3 drug product concentration 2 dose 3

Drug: SAR153191-P3 drug product

Group E'

ACTIVE COMPARATOR

SAR153191 - CIF3 drug product concentration 2 dose 3

Drug: SAR153191-C1F3 drug product

Interventions

SAR153191-P3 drug productDRUG

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

Also known as: SAR153191
Group AGroup CGroup C'Group D
SAR153191-P2 drug productDRUG

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

Also known as: SAR153191
Group BGroup B'
SAR153191-C1F3 drug productDRUG

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

Also known as: SAR153191
Group E'

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sarilumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 6, 2023

Study Start

July 9, 2010

Primary Completion

December 21, 2010

Study Completion

December 21, 2010

Last Updated

December 6, 2023

Record last verified: 2023-11