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

NCT07055321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-07-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ethris GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2024-07-08
Completion
2024-07-08

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07055321 on ClinicalTrials.gov