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

NCT07640425 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-12

No results posted yet for this study

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).

Conditions

  • Dupuytren Contracture
  • Dupuytren Disease of Finger

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

Sponsors & Collaborators

  • CONNEXT

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-23
Primary Completion
2027-07-01
Completion
2027-07-25
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640425 on ClinicalTrials.gov