Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns
Recruiting
Phase 2
Interventional Study
Burn
Burn Wounds - Partial Thickness (2nd Degree)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 144 (estimated)
- Sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd. · Industry
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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.
Trial Locations
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Eligibility Criteria
Inclusion criteria:
1. Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating;
2. 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 dist…
Contacts
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