NCT05541510

Evaluating the Safety and Efficacy of AD17002 Intranasal Spray in Treating Participants With Mild to Moderate COVID-19

A Phase 2/3, Double-blind, Randomized, Placebo-controlled, 3-arm Study to Evaluate the Safety, and Efficacy of AD17002 (LTh[αK]) Intranasal Spray in Male and Female Participants Aged 18 to 65 Years With Mild to Moderate COVID 19

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Advagene Biopharma Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

AD17002 enhances nasal mucosal innate immunity and has met safety and efficacy endpoints in studies of nasal adjuvants or intranasal immunomodulators. This study aims to evaluate the safety and effectiveness of AD17002 in treating patients with mild to moderate COVID-19. All participants will be randomly divided into 1:1:1 groups and will receive standard treatment. Additionally, participants will be given either a placebo, 20, or 40 μg of AD17002 via intranasal delivery, and clinical progress will be compared.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	AD17002 + Formulation buffer	Intranasal innate immune modulator
BIOLOGICAL	Placebo	Formulation buffer

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-08-05
• Completion: 2024-08-25
• First posted: 2022-09-15
• Last updated: 2025-09-10

Locations

3 sites across 1 country: Indonesia