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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Atavistik Bio, Inc
Study ID
NCT07601425
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hereditary Hemorrhagic Telangiectasia (HHT)
  • Osler Weber Rendu Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ATV-1601 — DRUG
    Administered orally, daily
  • Placebo — DRUG
    Administered orally, daily

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: 60 mg QD
    Active drug, once daily
  • Experimental: Part 1: 100 mg QD
    Active drug, once daily
  • Experimental: Part 1: 60 BID
    Active drug, twice daily
  • Experimental: Part 1: Placebo
    Control Arm

Primary Outcome Measure

Part 1: Safety and tolerability [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Study Director

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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