Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns

Phase 2

Recruiting

• Conditions: Burn; Burn Wounds - Partial Thickness (2nd Degree)
• Interventions: Drug: KJ101; Drug: Chymotrypsin; Drug: Placebo (Sodium Chloride Injection 0.9%)

• Registration Number: NCT07025408
• Lead Sponsor: Shanghai Bao Pharmaceuticals Co., Ltd.

Brief Summary

This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 for the debridement of deep second-degree burns. The trial will provide supporting evidence for subsequent Phase III trials.

Detailed Description

This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 in the debridement of deep second-degree burns. The aim is to provide supporting evidence for subsequent Phase III clinical trial.

The study comprises four treatment groups: KJ101 at a dose of 800 U/mL; KJ101 at a dose of 1200 U/mL; an active comparator group receiving chymotrypsin at a dose of 800 U/mL; and a placebo control group.

Approximately 144 screened and qualified subjects will be randomised at a ratio of 1:1:1:1 to one of the four groups. All interventions will be administered locally to the target wound at the following frequencies: once daily prior to complete necrotic tissue debridement, and then every other day post-debridement.

Treatment will continue until complete wound healing is achieved (with a maximum treatment duration of 28 days), after which there will be a one-week safety follow-up period will be conducted.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study Start: 2025-06-16
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-03-18
• Study Completion: 2026-08-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental-KJ101-Dose Group -1	KJ101	KJ101 , Dose Group -1 (800 U/mL)
Experimental-KJ101-Dose Group -2	KJ101	KJ101 , Dose Group -2 (1200 U/mL)
Active comparator	Chymotrypsin	Chymotrypsin (800 U/mL)
Placebo Comparator	Placebo (Sodium Chloride Injection 0.9%)	Placebo

Primary Outcome Measures

Name	Time	Method
Adverse events	day 35	Assessing the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) via the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary Outcome Measures

Name	Time	Method
The time required for burn wounds to heal completely.	day 3 to day 28	The time taken for the burn wound to reach full epithelialisation, i.e. complete healing.
Rate of complete healing of burn wounds.	day 28	The complete burn wound healing rate was calculated as follows: (Number of subjects with complete burn wound healing within 28 days of randomisation/Total number of subjects) x 100%.; Complete wound healing of burn wounds in patients was assessed using the criterion of 100% epithelialisation of the burn wound.
The time it takes to completely remove necrotic tissue from burn wound.	day 3 to day 28	Necrotic tissue in a wound was defined as inactive tissue that had lost its ability to heal due to irreversible cell death caused by thermal injury. The complete removal of necrotic tissue from a burn wound was defined as the point at which the wound was fully cleared of necrotic tissue, the base was clean, and new tissue had formed.
Pain intensity evaluation (VAS score)	day 1 to day 28	A visual analogue scale (VAS) is used to assess pain. The basic method involves a 10 cm scale divided into 10 points, with '0' and '10' at each end. '0' represents no pain, while '10' represents the most severe and intolerable pain possible.
Pharmacokinetics of KJ101 (Cmax)	day 28	Maximum observed serum concentration of KJ101 following dosing (Cmax)
Pharmacokinetics of KJ101 (AUC)	day 28	Area under the serum concentration versustime curve (AUC)
Pharmacokinetics of KJ101 (t1/2)	day 28	Half-life of KJ101
Pharmacokinetics of KJ101 (CL)	day 28	Clearance(CL) is a measure of the ability of the body to clear KJ101
Pharmacokinetics of KJ101 (Vz)	day 28	Vz = Volume of distribution during the elimination phase
Immunogenicity	day 28	Immunogenicity of KJ101 (Anti-KJ101 antibody) in patients

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China