MedTrace Logo

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

NCT05125211 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

GB001 recombinant peptide spray

administrated oral spray

DRUG

Placebo

administrated oral spray

Sponsors & Collaborators

  • Zhejiang Echon Biopharm Limited

    lead INDUSTRY

Principal Investigators

  • Feng Shao, MD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05125211 on ClinicalTrials.gov