NCT05845996

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2018

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

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

November 8, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

April 26, 2023

Last Update Submit

September 10, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Part 1: Number of participants with adverse event(AE)

    Number of participants with AE from baseline to day 127

    From baseline to day 127

  • 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 Outcomes (12)

  • Assessment of PK parameter: Cmax

    From Day 1 to Day 127 and to Day 155

  • Assessment of PK parameter: tmax

    From Day 1 to Day 127 and Day 155

  • Assessment of PK parameter: AUClast

    From Day 1 to Day 127

  • Assessment of PK parameter: AUC

    Area under the plasma concentration versus time curve extrapolated to infinity

  • Assessment of PK parameter: AUC0-tau

    From day 1 to Day 155

  • +7 more secondary outcomes

Study Arms (2)

SAR441344

EXPERIMENTAL

Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously

Drug: SAR441344Biological: Keyhole limpet hemocyanin

placebo

PLACEBO COMPARATOR

matching placebo

Drug: placeboBiological: Keyhole limpet hemocyanin

Interventions

SAR441344DRUG

Solution for intravenous/subcutaneous injection

SAR441344
placeboDRUG

Solution for intravenous/subcutaneous injection

placebo
Keyhole limpet hemocyaninBIOLOGICAL

Subcutaneous Lyophilized powder for reconstitution

SAR441344placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Having given written informed consent prior to undertaking any study-related procedure.

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

Study Sites (1)

PPD-Site Number:8400001

Austin, Texas, 78744, United States

Location

Related Links

MeSH Terms

Interventions

keyhole-limpet hemocyanin

Study Design

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

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

November 8, 2018

Primary Completion

April 10, 2020

Study Completion

April 10, 2020

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Locations

US(1)