Clinical Trials Directory

Trials / Completed

CompletedNCT02035605

A Phase 1 Study of an Investigational Drug, ALN-AT3SC, in Healthy Volunteers and Hemophilia A or B Patients

A Phase 1 Single-ascending and Multiple-ascending Dose, Safety, Tolerability and Pharmacokinetics Study of Subcutaneously Administered ALN-AT3SC in Healthy Adult Volunteers and Hemophilia A or B Patients (Moderate or Severe Hemophilia)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
51 (actual)
Sponsor
Sanofi · Industry
Sex
Male
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of ALN-AT3SC in healthy volunteers and Hemophilia A or B patients.

Conditions

Interventions

TypeNameDescription
DRUGALN-AT3SCAscending doses of ALN-AT3SC by subcutaneous (sc) injection
DRUGSterile Normal Saline (0.9% NaCl)Calculated volume to match active comparator

Timeline

Start date
2014-01-20
Primary completion
2017-07-20
Completion
2017-07-20
First posted
2014-01-14
Last updated
2020-12-19

Locations

14 sites across 5 countries: United States, Bulgaria, Russia, Switzerland, United Kingdom

Source: ClinicalTrials.gov record NCT02035605. Inclusion in this directory is not an endorsement.