This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults
with pulmonary hypertension (PH). The primary objective of this study is to evaluate the
safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical
measures of PH disease severity over 24 weeks.
Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with
pulmonary hypertension over 24 weeks
The study's objectives are to evaluate:
The changes in clinical and functional measures (pulmonary function test, pulmonary
vascular resistance, mean pulmonary arterial pressure, and 6 Minute Walk Distance Test)
in adults with PH treated with oral H01
The safety and tolerability of the use of oral H01 for PH over 24 weeks using health
criteria/evaluations (Common Terminology Criteria for Adverse Events (CTCAE), quality of
life (QOL) score, EMPHASIS-19 score and St George Respiratory Questionnaire (SGRQ)
To investigate the clinical efficacy, pharmacokinetic (PK) and pharmacodynamic (PD)
markers (serum HA concentration, inflammatory markers and cytokines, NT-proBNP, and H01
and metabolite serum concentrations) in this population following oral H01 use
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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