A Pilot, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Tolerability, Safety, and Pharmacokinetics of a Single Intra-articular Injection of CNTX-0066 in Participants with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain

2025-523737-26-00 Protocol CNTX-0066-OAi-101 Human pharmacology (Phase I) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol CNTX-0066-OAi-101

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruitment pending
Participants planned 20
Countries 1
Sites 1

Osteoarthritis of the knee

Key facts

Sponsor
Centrexion Therapeutics Corp.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Decision date (initial)
2026-02-24
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Osteoarthritis of the knee

VersionLevelCodeTermSystem organ class
21.1 LLT 10023476 Knee osteoarthritis 10028395

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centrexion Therapeutics Corp.

Sponsor organisation
Centrexion Therapeutics Corp.
Address
One Boston Place Suite 3520
City
Boston
Postcode
02108-4407
Country
United States

Scientific contact point

Organisation
Centrexion Therapeutics Corp.
Contact name
Chief Scientific Officer at NBCD

Public contact point

Organisation
Centrexion Therapeutics Corp.
Contact name
Chief Scientific Officer at NBCD

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Authorised, recruitment pending 20 1
Rest of world 0

Investigational sites

Denmark

1 site · Authorised, recruitment pending
Sanos A/S
Clinical department, Boulevarden 19g, 7100, Vejle

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-11-13 Denmark Acceptable
2026-02-20
2026-02-24