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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-07

Study Completion Date

2018-01-12

Brief Summary

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

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Detailed Description

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Conditions

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Transthyretin-mediated Amyloidosis (ATTR Amyloidosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ALN-TTRSC02

Group Type ACTIVE_COMPARATOR

ALN-TTRSC02

Intervention Type DRUG

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

Sterile normal saline 0.9% for SC administration

Group Type PLACEBO_COMPARATOR

Sterile Normal Saline (0.9% NaCl)

Intervention Type DRUG

Calculated volume to match active comparator

Interventions

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ALN-TTRSC02

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

Intervention Type DRUG

Sterile Normal Saline (0.9% NaCl)

Calculated volume to match active comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects, age 18 to 65 years, inclusive.
* Body mass index (BMI) ≥18.0 kg/m2 and ≤30 kg/m2 assessed at Screening.
* No clinically significant health concerns, as determined by medical history and physical examination, in the opinion of the Investigator.
* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception, willing and able to comply with the study requirements and to provide written informed consent.
* For Japanese cohorts, subjects of Japanese descent are defined as people carrying a Japanese passport, descendants of 4 Japanese grandparents, and have not been outside Japan for more than 5 years.

Exclusion Criteria

* Clinically relevant history or presence of respiratory, gastrointestinal, renal, cardiovascular, hepatic, hematological, lymphatic, neurological, psychiatric, musculoskeletal, genitourinary, immunological, and other inflammatory diseases, or dermatological or connective tissue diseases or disorders.
* Active serious mental illness or psychiatric disorder.
* Clinically significant ECG abnormalities. Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant.
* Known history of allergic reaction to an oligonucleotide or GalNAc.
* History of intolerance to subcutaneous injection.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes