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Pharmacokinetics and Safety of SAR441236

NCT03705169 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-01-12

Study results available
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Summary

The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against the human immunodeficiency virus (HIV).

Conditions

Interventions

BIOLOGICAL

SAR441236

Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)

BIOLOGICAL

Placebo

Administered by intravenous (IV) infusion(s) or subcutaneous (SC) injection(s)

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • ModeX Therapeutics, An OPKO Health Company

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Athe Tsibris, MD, MS · Brigham and Women's Hospital, Harvard Medical School

  • Daniel R. Kuritzkes, MD · Brigham and Women's Hospital Therapeutics CRS, Harvard Medical School

  • Pablo Tebas, MD · Penn Therapeutics CRS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2022-04-04
Completion
2022-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03705169 on ClinicalTrials.gov