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

NCT07025408 | Recruiting Phase 2

• 1 other identifier: SHBJ-KJ101-002
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn; Burn Wounds - Partial Thickness (2nd Degree)

Outcome Measures

Primary Outcomes (1)

• Adverse events

  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.

  day 35

Secondary Outcomes (10)

• The time required for burn wounds to heal completely.

  day 3 to day 28

• Rate of complete healing of burn wounds.

  day 28

• The time it takes to completely remove necrotic tissue from burn wound.

  day 3 to day 28

• Pain intensity evaluation (VAS score)

  day 1 to day 28

• Pharmacokinetics of KJ101 (Cmax)

  day 28

Study Arms (4)

Experimental-KJ101-Dose Group -1

EXPERIMENTAL

KJ101 , Dose Group -1 (800 U/mL)

Drug: KJ101

Experimental-KJ101-Dose Group -2

EXPERIMENTAL

KJ101 , Dose Group -2 (1200 U/mL)

Drug: KJ101

Active comparator

ACTIVE COMPARATOR

Chymotrypsin (800 U/mL)

Drug: Chymotrypsin

Placebo Comparator

PLACEBO COMPARATOR

Placebo

Drug: Placebo (Sodium Chloride Injection 0.9%)

Interventions

KJ101 DRUG

1. Clean the wound before applying medication. 2. Apply KJ101 (800U/mL) to the wound. 3. Apply a standard wound dressing after treatment. 4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).

Experimental-KJ101-Dose Group -1; Experimental-KJ101-Dose Group -2

Chymotrypsin DRUG

1. Clean the wound before applying medication. 2. Apply Chymotrypsin (800U/mL) to the wound. 3. Apply a standard wound dressing after treatment. 4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).

Active comparator

Placebo (Sodium Chloride Injection 0.9%) DRUG

1. Clean the wound before applying medication. 2. Apply Placebo (Sodium Chloride Injection 0.9%) to the wound. 3. Apply a standard wound dressing after treatment. 4. Apply once daily until complete debridement of necrotic tissue has been achieved. After debridement, apply the medication every other day until the wound closes (maximum treatment duration: 28 days).

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating;
• Clinically diagnosed with superficial or deep II degree burns within 72 hours of injury, with a total burn area of ≤30% TBSA. The target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm².
• Subjects of childbearing age must agree to use effective and safe contraceptive methods during the treatment period and for three months after the final administration.

You may not qualify if:

• Individuals who are known to be allergic to any component of the test drug or who have a tendency to allergies.
• Burns caused by specific factors, such as electrical or chemical burns.
• Subjects with shock or inhalation lung injury;
• Subjects with target wounds complicated by inflammatory skin diseases (e.g. atopic dermatitis, eczema or psoriasis), or who have undergone enzymatic debridement (e.g. with collagenase, papain, bromelain, chymotrypsin or trypsin).
• Subjects who, during screening, are judged by the investigator to have other severe systemic infections requiring systemic treatment;
• Abnormal liver or kidney function.

Sponsors & Collaborators

• Shanghai Bao Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Chymotrypsin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 17, 2025
• Study Start: June 16, 2025
• Primary Completion: March 18, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)