RECRUITING

A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to: * evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers * evaluate the efficacy, safety, tolerability and PD of multiple doses of ALN-6400 in adult patients with HHT

Official Title

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-6400 in Adult Healthy Volunteers and Multiple Dose ALN-6400 in Adult Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

Quick Facts

Study Start:2024-11-11
Study Completion:2028-06-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06659640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Alnylam Clinical Trial Information Line
CONTACT
1-877-ALNYLAM
clinicaltrials@alnylam.com
Alnylam Clinical Trial Information Line
CONTACT
1-877-256-9526
clinicaltrials@alnylam.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Alnylam Pharmaceuticals

Study Locations (Sites)

Clinical Trial Site
Cypress, California, 90630
United States

Collaborators and Investigators

Sponsor: Alnylam Pharmaceuticals

  • Medical Director, STUDY_DIRECTOR, Alnylam Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-11
Study Completion Date2028-06-22

Study Record Updates

Study Start Date2024-11-11
Study Completion Date2028-06-22

Terms related to this study

Keywords Provided by Researchers

  • siRNA
  • RNAi therapeutic
  • Plasminogen
  • PLG
  • HHT
  • Osler-Weber-Rendu
  • epistaxis

Additional Relevant MeSH Terms

  • Hereditary Hemorrhagic Telangiectasia