RecruitingPhase 1Phase 2NCT07640425

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

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

Sponsor

CONNEXT

Enrollment

60 participants

Start Date

Jul 23, 2024

Study Type

INTERVENTIONAL

Conditions

Dupuytren Disease of Finger Dupuytren Contracture

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called [Step1] CNT201 First-dose, a drug called [Step1] CNT201 High-dose, and others for people with dupuytren contracture and dupuytren disease of finger. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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