Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
93 (estimated)
Sponsor
Diagonal Therapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with hereditary hemorrhagic telangiectasia (HHT) to participate in testing a new treatment called DIAG723. Participants will receive either the treatment or a placebo and will be monitored for safety and effectiveness over several weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with hereditary hemorrhagic telangiectasia.
I have normal liver and kidney function.
I have a history of nosebleeds and anemia or need for transfusions.
I have hereditary hemorrhagic telangiectasia with high blood pressure in my lungs.
You may not be able to join if
I have an active or recent infection.
I have had a blood clot in the past few months.
I have taken anti-angiogenic drugs in the last 6 weeks.
I am pregnant or breastfeeding.
I have participated in another clinical trial recently.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 i…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Active or r…
Inclusion Criteria:
* 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
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
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