Find Hereditary Hemorrhagic Telangiectasia Clinical Trials Near You
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)
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients ≥18 years with a clinical or genetic diagnosis of HHT
• Adequate hepatic and renal function
• Part B: Epistaxis and anemia or transfusion/iron history
• Part C: HHT with documented pre-capillary pulmonary arterial hypertension
Locations
Other Locations
Australia
Diagonal Investigational Site
NOT_YET_RECRUITING
Camperdown
Diagonal Investigational Site
RECRUITING
East Melbourne
Diagonal Investigational Site
NOT_YET_RECRUITING
Herston
Diagonal Investigational Site
WITHDRAWN
Herston
Diagonal Investigational Site
NOT_YET_RECRUITING
Parkville
Diagonal Investigational Site
RECRUITING
Randwick
Diagonal Investigational Site
NOT_YET_RECRUITING
West Perth
Canada
Diagonal Investigational Site
NOT_YET_RECRUITING
Laval
Diagonal Investigational Site
NOT_YET_RECRUITING
Toronto
Diagonal Investigational Site
NOT_YET_RECRUITING
Toronto
New Zealand
Diagonal Investigational Site
RECRUITING
Grafton
Contact Information
Primary
Diagonal Therapeutics
clinicalinfo@diagonaltx.com
339-233-4291
Time Frame
Start Date:2026-06-04
Estimated Completion Date:2027-12-31
Participants
Target number of participants:93
Treatments
Experimental: DIAG723
Participants receive DIAG723 administered subcutaneously.~Part A (dose-escalation): Single ascending dose across planned cohorts, randomized 3:1 DIAG723:placebo.~Part B (multi-dose HHT): Multiple-dose regimens over 13 weeks (7 doses administered every other week), randomized 2:1.~Part C (multi-dose HHT + PAH): Same 13-week multi-dose regimen in patients with pulmonary arterial hypertension, randomized 4:1.~Doses/regimens in Parts B and C are selected based on Part A safety and PK data.
Placebo_comparator: Placebo Comparator
Participants receive placebo (sterile normal saline, 0.9% NaCl) administered subcutaneously in a volume matched to DIAG723 to maintain blinding.~Matching single-dose administration in Part A. Matching multi-dose regimens (every-other-week dosing for 13 weeks) in Parts B and C.~Randomization ratios consistent with each study part (3:1, 2:1, 4:1).