A double-blind, placebo-controlled, randomised phase 1/2a study to evaluate the safety, tolerability and pharmacokinetics of single and repeated subcutaneous ascending-doses of DX243 in healthy volunteers followed by an extension to assess 1-month safety and preliminary efficacy in patients with mild age-related hearing loss.

2023-505778-14-00 Protocol DX243-101 Phase I and Phase II (Integrated) - First administration to humans Ongoing, recruiting

Start 19 Sep 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol DX243-101

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - First administration to humans
Status Ongoing, recruiting
Participants planned 116
Countries 1
Sites 1

Age related hearing loss

Key facts

Sponsor
Dendrogenix
Participant type
Healthy volunteers, Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
19 Sep 2023 → ongoing
Decision date (initial)
2023-08-23
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

Age related hearing loss

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dendrogenix

Sponsor organisation
Dendrogenix
Address
Avenue De L'hopital 11
City
Liege
Postcode
4000
Country
Belgium

Scientific contact point

Organisation
Dendrogenix
Contact name
Nicolas Caron

Public contact point

Organisation
Dendrogenix
Contact name
Nicolas Caron

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruiting 116 1
Rest of world — 0 —

Investigational sites

Belgium

1 site · Ongoing, recruiting
Centre hospitalier universitaire de Liege
CHU Liège, Avenue De L'Hopital 1, 4000, Liege

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2023-09-19 2023-09-19

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-06-05 Belgium Acceptable with conditions
2023-08-23
 2023-08-23
2 NON SUBSTANTIAL MODIFICATION NSM-2 2023-09-05 Belgium Acceptable with conditions
2023-08-23
 2023-09-05
3 NON SUBSTANTIAL MODIFICATION NSM-3 2023-09-14 Belgium Acceptable with conditions
2023-08-23
 2023-09-14
4 SUBSTANTIAL MODIFICATION SM-2 2023-09-20 Belgium Acceptable
2023-10-26
 2023-10-26
5 SUBSTANTIAL MODIFICATION SM-3 2023-11-10 Belgium Acceptable
2023-12-21
 2023-12-22
6 SUBSTANTIAL MODIFICATION SM-4 2024-02-12 Belgium Acceptable
2024-03-29
 2024-03-29
7 SUBSTANTIAL MODIFICATION SM-5 2024-07-02 Belgium Acceptable
2024-08-20
 2024-08-20
8 SUBSTANTIAL MODIFICATION SM-7 2025-02-05 Belgium Acceptable
2025-03-03
 2025-03-03
9 SUBSTANTIAL MODIFICATION SM-8 2025-04-08 Belgium Acceptable
2025-05-19
 2025-05-19
10 SUBSTANTIAL MODIFICATION SM-10 2025-05-28 Belgium Acceptable
2025-06-12
 2025-06-12
11 NON SUBSTANTIAL MODIFICATION NSM-5 2025-06-17 Belgium Acceptable
2025-06-12
 2025-06-17
12 SUBSTANTIAL MODIFICATION SM-11 2025-12-02 Belgium Acceptable
2026-02-19
 2026-02-19