Clinical trial to evaluate the safety, tolerability and effectiveness of a medicinal nasal insert in the treatment of chronic hay fever.- Inspicare

2026-525200-99-00 Protocol protocol_v2 Human pharmacology (Phase I) - First administration to humans Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol protocol_v2

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Authorised, recruitment pending
Participants planned 25
Countries 1
Sites 1

Chronic allergic rhinitis

Key facts

Sponsor
Dianosic
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Decision date (initial)
2026-05-21
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Chronic allergic rhinitis

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dianosic

Sponsor organisation
Dianosic
Address
Batiment Ph 8, 8 Place De L Hopital 8 Place De L Hopital
City
Strasbourg
Postcode
67000
Country
France

Scientific contact point

Organisation
Dianosic
Contact name
Chief Scientific Officer

Public contact point

Organisation
Dianosic
Contact name
Chief Scientific Officer

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Authorised, recruitment pending 25 1
Rest of world 0

Investigational sites

Netherlands

1 site · Authorised, recruitment pending
Amsterdam University Medical Center, VUmc Boelelaan
Ear, Nose and Throat (AMC), De Boelelaan 1117, 1081 HV, Amsterdam

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-02-10 Netherlands Acceptable
2026-05-20
2026-05-21