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ACTIVE NOT RECRUITING
NCT05125211
PHASE1

Safety,Tolerability,and Pharmacokinetics Profiles of GB001 Recombinant Peptide Spray in Healthy Subjects

Sponsor: Zhejiang Echon Biopharm Limited

View on ClinicalTrials.gov

Summary

This trial is conducted in China. The aim of this clinical trial is to assess the safety , tolerability and pharmacokinetics profiles of GB001 by single ascending dose and multiple ascending doses in healthy subjects after topical buccal delivery.

Official title: A PhaseⅠRandomised, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Characteristics of the Oral Topical Use of GB001 Recombinant Peptide Spray in Chinese Healthy Adult Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

91

Start Date

2022-08-08

Completion Date

2026-05-29

Last Updated

2025-04-09

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

GB001 recombinant peptide spray

administrated oral spray

DRUG

Placebo

administrated oral spray

Locations (1)

The First Affiliated Hospital of Nanjing medical University

Nanjing, Jiangsu, China