A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
ConditionPulmonary Arterial Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorApollo Therapeutics Ltd
About this trial
The AP13CP02 study is a phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (SC) injections of APL-9796 are for patients with PH. The study will also assess how effective APL-9796 could be for treating patients with PH and whether the body produces antibodies working against APL-9796.
The trial will be conducted in two parts:
* Part A: Up to 36 adults with WHO Group 1 Pulmonary arterial hypertension (PAH). * Part B (optional): Up to 12 adults with WHO Group 3 - PH associated with ILD (PH-ILD).
Eligibility criteria
Qualifiers
Participant must be 18 to 80 years of age inclusive
Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening.
WHO Functional Class II or III
Participant has the CardioMEMS PA Sensor implanted.
Disqualifiers
Hospital admission related to PH within 3 months prior to Screening.
Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered by the Investigator
Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease
History of left-sided heart disease and/or clinically significant cardiac disease
Trial design
Treatments tested in this trial
- APL-9796
- APL-9796
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov