DIAG723 in Adults With Hereditary Hemorrhagic Telangiectasia (NCT07623525)
A Phase 1/2, First-in-Human, Multicenter, Ascending Single-Dose and Multi-Dose Study to Assess the Safety of DIAG723, a Novel Bispecific ALK-1 and BMPRII Agonist Antibody in Adult Patients With Hereditary Hemorrhagic Telangiectasia (DIAMOND Trial)
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 1/2, randomized, double-blind, placebo-controlled, first-in-human study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of subcutaneously administered DIAG723 in adult patients with hereditary hemorrhagic telangiectasia (HHT). The study consists of three parts: Part A (dose escalation): Single ascending subcutaneous doses of DIAG723 are evaluated in sequential cohorts to assess safety, tolerability, and pharmacokinetics. Part B (dose expansion): Multiple doses of DIAG723 administered over 13 weeks are evaluated in patients with HHT to assess safety and preliminary efficacy. Part C (dose expansion): Multiple doses of DIAG723 administered over 13 weeks are evaluated in patients with HHT and concomitant pulmonary arterial hypertension to assess safety and exploratory clinical effects in this population. Participants will be randomized within each study part to receive DIAG723 or placebo. The study includes dose escalation in Part A and dose expansion in Parts B and C.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (6 items).
Location: Chris O'Brien Lifehouse — Camperdown, New South Wales
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Active or recent systemic infection
- Recent thromboembolic events
- Use of anti-angiogenic drugs within 6 weeks
- Pregnancy or lactation
- Recent participation in another investigational study
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (12 Sites)
- Chris O'Brien Lifehouse — Camperdown, New South Wales
- Royal Prince Alfred Hospital — Camperdown, New South Wales
- Scientia Clinical Research Ltd — Randwick, New South Wales
- Nucleus Network — Herston, Queensland
- Royal Brisbane and Women's Hospital — Herston, Queensland
- Doherty Clinical Trials — East Melbourne, Victoria
- Royal Melbourne Hospital — Parkville, Victoria
- Perth Blood Institute — West Perth, Western Australia
- St. Michael's Hospital — Toronto, Ontario
- BioPharma — Toronto, Ontario
- Altasciences Company — Laval, Quebec
- New Zealand Clinical Research - Auckland — Grafton, Auckland
📞 Contact the Study Coordinator
Phone: (339) 233-4291
Email: clinicalinfo@diagonaltx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hereditary Hemorrhagic Telangiectasia
- CHORUS - Comprehensive HHT Outcomes Registry of the United States (Formerly OUR HHT Registry) — Toronto, Ontario
- Comprehensive HHT Outcomes Registry of the United States (CHORUS) — Birmingham, Alabama
- Bevacizumab In Hereditary Hemorrhagic Telangiectasia — Boston, Massachusetts
- A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT) — Birmingham, Alabama
- Effects of Pazopanib on Hereditary Hemorrhagic Telangiectasia Related Epistaxis and Anemia (Paz) — Los Angeles, California
Explore by condition: All Hereditary Hemorrhagic Telangiectasia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.