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ALN-6400

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    Accepts Healthy Volunteers
I'm interested
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Objective

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

Details

Full study title A Phase 1/2, Randomized, Double-blind,Placebo-controlled,2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single DoseALN-6400 in Adult Healthy Volunteers and Multiple DoseALN-6400 in Adult Patients with Hereditary HemorrhagicTelangiectasia (HHT)
Protocol number OCR48935
ClinicalTrials.gov ID NCT06659640
Phase Phase 1/Phase 2

Eligibility

Inclusion Criteria -

Part A:

  • Is a healthy adult volunteer

Part B:

  • Is an adult patient with a clinical diagnosis of HHT

Exclusion Criteria -

Part A:

  • Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)

  • Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection

  • Has an estimated glomerular filtration (eGFR) of 2×ULN

  • Has total bilirubin >1.5×ULN

  • Has eGFR of

Lead researcher

  • Ali Ataya, MD
    Critical Care Medicine Specialist, Pulmonologist (Lung Specialist)

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.