NCT07055321

A Phase 1, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of ETH47 in Healthy Participants

A Phase 1, First-in-human, Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of ETH47 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Ethris GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics and target engagement of ETH47 in healthy participants following single intranasal and single inhaled administration

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ETH47	Dose level 1; single intranasal administration
DRUG	ETH47	Dose level 2; single intranasal administration
DRUG	ETH47	Dose level 3; single intranasal administration
DRUG	ETH47	Dose level 4; single intranasal administration
DRUG	ETH47	Dose level 5; single intranasal administration
DRUG	ETH47	Dose level 1; single inhaled administration
DRUG	ETH47	Dose level 2; single inhaled administration
DRUG	ETH47	Dose level 3; single inhaled administration
DRUG	ETH47	Dose level 4; single inhaled administration

Timeline

• Start date: 2023-11-29
• Primary completion: 2024-07-08
• Completion: 2024-07-08
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: United Kingdom