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Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
Sponsor: CONNEXT
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
[Step1] CNT201 First-dose
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): First-dose
[Step1] CNT201 Low-dose
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Low-dose
[Step1] CNT201 Intermediate-dose
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): Intermediate-dose
[Step1] CNT201 High-dose
CNT201: recombinant collagenase • Unit Dose Strength(s)/ Dosage Level(s): High-dose
[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
[Step2] Placebo
• Saline
Locations (1)
A R Houston Medical Pty Ltd.
Kippa-Ring, Queensland, Australia