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RECRUITING
NCT07640425
PHASE1/PHASE2

Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture

Sponsor: CONNEXT

View on ClinicalTrials.gov

Summary

This trial is a multicenter, Phase 1/2, study to assess the safety, tolerability, efficacy, PK, and immunogenicity of CNT201 in adult participants with DC (Dupuytren's Contracture).

Official title: A Phase 1/2, Multicenter, Dose Escalating, Dose Expanding, Adaptive Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of Collagenase CNT201 in Adult Participants With Dupuytren's Contracture

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-07-23

Completion Date

2027-07-25

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

[Step1] CNT201 First-dose

CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): First-dose

DRUG

[Step1] CNT201 Low-dose

CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Low-dose

DRUG

[Step1] CNT201 Intermediate-dose

CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose

DRUG

[Step1] CNT201 High-dose

CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): High-dose

DRUG

[Step2] CNT201

eligible participants will be randomized to 1 of 2 or more treatment arms, depending on the number of CNT201 doses selected for administration in Step 2

DRUG

[Step2] Placebo

• Saline

Locations (1)

A R Houston Medical Pty Ltd.

Kippa-Ring, Queensland, Australia