NCT04891354View on ClinicalTrials.gov

A First-in-Human Study to Assess the Safety and Tolerability of PDNO

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

February 2, 2021

Primary Completion Date

May 25, 2022

Study Completion Date

May 25, 2022

Conditions
Pulmonary Hypertension
Interventions
DRUG

PDNO

PDNO consists of propylene glycol (1,2-propanediol, PD) chemically combined with NO (to be donated). The drug substance is formulated as an inherent mixture of 4 structure analogues. The mixture consists of an equilibrium of the 2 regioisomers 1-(nitrosooxy) propan-2-ol and 2-(nitrosooxy) propan-1-ol. In addition, each regioisomer is a racemic mixture.

DRUG

Sodium chloride (placebo)

Placebo (NaCl, commercially available dilution solution for parenteral use, 9 mg/mL)

Trial Locations (1)

75185

CTC Clinical Trial Consultants AB, Uppsala

All Listed Sponsors
lead

Attgeno AB

INDUSTRY

NCT04891354 - A First-in-Human Study to Assess the Safety and Tolerability of PDNO | Biotech Hunter | Biotech Hunter