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A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy Subjects

NCT02797847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-09-21

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC02 in healthy subjects.

Conditions

  • Transthyretin-mediated Amyloidosis (ATTR Amyloidosis)

Interventions

DRUG

ALN-TTRSC02

Ascending doses of ALN-TTRSC02 by subcutaneous (SC) injection

DRUG

Sterile Normal Saline (0.9% NaCl)

Calculated volume to match active comparator

Sponsors & Collaborators

Principal Investigators

  • John Vest, MD, PhD · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-07
Primary Completion
2018-01-12
Completion
2018-01-12

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT02797847 on ClinicalTrials.gov