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drugset / Trial / NCT05125211

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

NCT05125211 ↗

Phase 1 Unknown 91 enrolled Zhejiang Echon Biopharm Limited
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-08-08
Primary completion
2022-11-18
Completion
2026-05-29

Drugs

EvaluationDrugModalityDoseRoute
Subject GB001 recombinant peptide spray Peptide 0.054 mg Oral
Subject GB001 recombinant peptide spray Peptide 0.108 mg Oral
Subject GB001 recombinant peptide spray Peptide 0.216 mg Oral
Subject GB001 recombinant peptide spray Peptide 0.432 mg Oral
Subject GB001 recombinant peptide spray Peptide 0.864 mg Oral

Indications

No indication recorded.