Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR02 in healthy volunteer subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02797847

Transthyretin-mediated Amyloidosis (ATTR Amyloidosis)

COMPLETED PHASE1

Trial to Evaluate Safety and Tolerability of ALN-TTR01 in Transthyretin (TTR) Amyloidosis

NCT01148953

Transthyretin Mediated Amyloidosis (ATTR)

COMPLETED PHASE1

Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis

NCT05521022

Amyloidosis; Systemic

RECRUITING PHASE1

Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

NCT02613182

AL Amyloidosis

TERMINATED PHASE2

First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)

NCT06351592

Amyotrophic Lateral Sclerosis (ALS) Mutation in the Superoxide Dismutase-1 (SOD1) Gene

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

TTR-mediated Amyloidosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ALN-TTR02

Group Type ACTIVE_COMPARATOR

ALN-TTR02

Intervention Type DRUG

Dose levels between 0.01 and 0.5 mg/kg by intravenous (IV) infusion

Sterile Normal Saline (0.9% NaCl)

Group Type PLACEBO_COMPARATOR

Sterile Normal Saline (0.9% NaCl)

Intervention Type DRUG

Calculated volume to match active comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALN-TTR02

Dose levels between 0.01 and 0.5 mg/kg by intravenous (IV) infusion

Intervention Type DRUG

Sterile Normal Saline (0.9% NaCl)

Calculated volume to match active comparator

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body mass index must be between 18.0 kg/m2 and ≤ 31.5 kg/m2;
* Non-smokers for at least 3 months preceding screening;
* Females subjects must be of non-childbearing potential e.g., post-menopausal or pre-menopausal with surgical sterilization;
* Males agree to use appropriate contraception;
* Medical history must be verified by either a personal physician or medical practitioner as appropriate;
* Willing to give written informed consent and are willing to comply with the study requirements.

Exclusion Criteria

* Known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
* Multiple drug allergies or know sensitivity to oligonucleotide
* History of drug abuse and/or alcohol abuse
* Receiving an investigational agent within 3 months prior to study drug administration
* Subjects with safety laboratory test results deemed clinical significant by the Investigator;
* Received prescription drugs within 4 weeks of first dosing
* Subjects who have donated more than 500 mL of blood within the 3 months prior to ALN-PCS02 or placebo administration;
* Subjects who have used prescription drugs within 4 weeks of first dosing
* Considered unfit for the study by the Principal Investigator
* Employee or family member of the sponsor or the clinical study site personnel

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes