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RecruitingAccepts healthy volunteersPhase 1/Phase 2

Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)

Atavistik Bio, Inc · NCT07601425

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
100
US sites recruiting
6
Study start
July 27, 2026
Record last updated
October 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT. Part 1 is a randomized, double-blind, placebo-controlled study evaluating 3 dosing regimens of ATV-1601. Patients completing Part 1 may participate in the Part 2 open-label extension to receive ATV-1601.

Being studied: ATV-1601; Placebo

Conditions: Hereditary Hemorrhagic Telangiectasia (HHT); Osler Weber Rendu Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Ability to provide informed consent prior to any study-specific procedures
  • Confirmed diagnosis of hereditary hemorrhagic telangiectasia (HHT) based on Curaçao criteria
  • Moderate to severe HHT with an ESS ≥ 4
  • Anemia at Screening and/or requirement for at least 1 red-cell unit (RUE) in the previous 6 months
  • Adequate hematologic, renal, and hepatic function per protocol-defined laboratory criteria
  • Use highly effective contraception during the study and for a protocol-defined period after last dose

Exclusion Criteria

  • Clinically significant abnormalities of glucose metabolism including diagnosed Type 1 or uncontrolled Type 2 diabetes
  • Chronic cardiac disease, or cardiac rhythm abnormalities
  • History of significant cardiovascular, hepatic, renal, or hematologic disease not related to HHT that may confound study results
  • Use of prohibited concomitant medications within a protocol-defined washout period prior to first dose (including strong CYP modulators and certain herbal supplements)
  • Recent (within 6 weeks) major surgery or local ablative procedures, or procedures on nasal telangiectasias
  • Prior AKT inhibitor
  • Pregnant or breastfeeding women

Additional Criteria for Open-Label Extension:

  • Participants must complete the double-blind treatment period (Part 1)

Recruiting US locations

  • Arizona Pulmonary Specialists

    Phoenix, AZ 85013

    Site contact: Study Director Atavistik · 857-285-5400 · studydirector@atavistikbio.com

  • Augusta University Medical Center

    Augusta, GA 30912

    Site contact: Study Director Atavistik · 857-285-5400 · studydirector@atavistikbio.com

  • Innovative Hematology

    Indianapolis, IN 46260

    Site contact: Study Director Atavistik · 857-285-5400 · studydirector@atavistikbio.com

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Study Director Atavistik · 857-285-5400 · studydirector@atavistikbio.com

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Study Director Atavistik · 857-285-5400 · studydirector@atavistikbio.com

  • University of Utah Health Sciences Center

    Salt Lake City, UT 84132

    Site contact: Study Director Atavistik · 857-285-5400 · studydirector@atavistikbio.com

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Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic… (NCT07601425) | Bored Studies