RecruitingPhase 2ACTRN12624000664549

CNT201 Phase 1/2 study in Adults with 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 Co., Ltd

Enrollment

36 participants

Start Date

Jul 23, 2024

Study Type

Interventional

Conditions

Dupuytren’s Contracture

Summary

Study details This registration is for Step 1 of a 2 step study investigating CNT201. CNT201 is a recombinant collagenase product being developed by the Sponsor, which is being studied for the treatment of Dupuytren’s Contracture (DC) This is an adaptive clinical study design containing 2 steps (Dose escalation and Dose expansion). Step 1 (dose escalation) uses an open-label design. Participants will be enrolled to a dose cohort with the CNT201 dose to be administered determined by the cohort to which the participant is enrolled; Afte a screening period of upto 30 days, eligible participants will be enrolled into 1 of 4 cohorts (provisional 5th cohort) and will be administered a single dose of CNT201 at 1 of 4 CNT201 dose levels: First-, low-, intermediate-, or high-dose (Cohort 1 to Cohort 4, respectively) within a treatment cycle. The treatment period will consist of an intralesional injection of CNT201 (Day 1), followed by a series of safety, efficacy, PK, and immunogenicity evaluations for 28 days (until Day 29) with primary efficacy assessed on Day 29 with an additional 28 days of safety follow-up thereafter (until Day 57). If there are no safety concerns on Day 57 as assessed by the investigator, Day 57 will serve as the End-of-Study (EOS) visit for Step 1. Cohort 1 will enroll 4 participants; all other cohorts will enroll 8 participants.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Dupuytren's contracture is a condition where the connective tissue in the palm of the hand slowly tightens, pulling one or more fingers into a bent position that can no longer be straightened. CNT201 is a new injectable enzyme (collagenase) developed by Connext Co., Ltd that is designed to break down the cord of thickened tissue causing the contracture, offering a potential non-surgical treatment. This Phase 1/2 dose escalation study is testing CNT201 for the first time in humans — first to find the right dose and make sure it is safe, then to assess how well it works. Participants will receive a single injection into the affected cord, followed by careful safety monitoring over 57 days. You may be eligible if you are aged 18–75, have a primary Dupuytren's contracture with at least a 20-degree bend in a finger (not the thumb), and have not previously been treated with collagenase (e.g. Xiaflex/Xiapex), surgery, or needle aponeurotomy for Dupuytren's. People with active HIV, TB, severe cardiovascular disease, rheumatoid arthritis, or a known allergy to collagenase are not eligible.

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

Interventional Product (IP): CNT201 recombinant collagenase Dosage form: Injectable Solution Mode of administration: Intralesional injection by a syringe to a single cord In Step 1 (Dose escalatio

Interventional Product (IP): CNT201 recombinant collagenase Dosage form: Injectable Solution Mode of administration: Intralesional injection by a syringe to a single cord In Step 1 (Dose escalation), eligible participants will receive single injection of the designated CNT201 of 1 of 4 dose levels (with a provisional 5th dose level) on Day 1 of a 28 day treatment cycle with additional follow up until Day 57. A range of doses starting at 0.1 mg/kg up to 0.8 mg/kg or lower, as determined by the safety results, will be studied across up to 5 participant cohorts. Dose escalation to next higher dose cohort will be made by the safety review committee. 4 participants will be enrolled in Cohort 1 and 8 participants in all other cohorts. The SRC might recommend an additional optional fifth cohort that is a de-escalating dose lower than Cohort 1 or any dose between Cohort 1 and Cohort 4 in Step 1 (dose escalation). This optional fifth dose would be lower than the last completed highest dose level if emerging data suggests that exploring an intermediate dose before proceeding to Step 2 is warranted. However, it should not exceed the last completed highest dose level (i.e. optional fifth cohort will be 0.5mg/cord, if Cohort 3 (0.6mg/cord) was completed. And optional fifth cohort will be 0.7mg/cord, if Cohort 4 (0.8mg/cord) was completed). We will not escalate higher than high dose (0.8mg/cord).. Only authorized study center staff will supply and administer the study treatment.

Locations(1)

Griffith University Clinical Trials Unit - Southport

QLD, Australia

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ACTRN12624000664549