Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Bao Pharmaceuticals Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- KJ101
- Chymotrypsin
- Placebo (Sodium Chloride Injection 0.9%)
Treatment groups
144 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov