NCT04891354

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

A Single-Blind, Placebo-Controlled, First-in-Human Study to Assess the Safety and Tolerability of PDNO Administered as an Intravenous Infusion in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Attgeno AB · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, single-blind, placebo-controlled, single-centre study designed to assess the safety and tolerability of PDNO in healthy male and female subjects. In addition, the exposure of 1,2 propanediol (PD) will be evaluated. There are 2 parts to the study: Part I: single ascending dose (SAD), 7 cohorts, 30 minutes intravenous (i.v.) infusion of placebo followed by 1-hour i.v. infusion of PDNO to assess safety, tolerability and PD exposure in healthy male and female subjects. Part II: ascending doses of PDNO in 2 cohorts, 30 minutes i.v. infusion of placebo followed by 3 ascending doses of PDNO in cohort 1 and 3 ascending doses of PDNO in cohort 2. The first 2 doses in each cohort will be i.v. infused for 30 minutes whereas the last will be i.v. infused for 3 hours to assess safety, tolerability and PD exposure in healthy male and female subjects. If indicated by emerging data and recommended by the internal safety review committee (iSRC), 2 additional dose groups/cohorts (4+4 subjects) may be added to Part I and 1 dose group/cohort (4 subjects) may be added to Part II.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-02-02
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2021-05-18
• Last updated: 2023-01-19

Locations

1 site across 1 country: Sweden