[Translation] A randomized, double-blind, placebo-controlled phase I/II clinical trial evaluating the safety, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of KJ101 administered orally in trial participants.

I期试验第一阶段：主要目的：KJ101的安全性和耐受性。次要目的：KJ101的药代动力学特征、免疫原性。第二阶段：主要目的：评估健康胃镜检查试验参与者单次口服KJ101的安全性。次要目的：评估胃镜检查前口服不同剂量KJ101对于提高胃镜视野清晰度的有效性并探索II期推荐剂量（RP2D）、免疫原性。 II期试验主要目的：评估胃镜检查前单次口服不同剂量KJ101对于提高胃镜视野清晰度的有效性。次要目的：评估胃镜检查试验参与者单次口服KJ101的安全性、耐受性和免疫原性。

[Translation]

Phase I Trial Phase 1: Primary Objective: Safety and tolerability of KJ101. Secondary Objective: Pharmacokinetics and immunogenicity of KJ101. Phase 2: Primary Objective: To evaluate the safety of a single oral dose of KJ101 in healthy participants undergoing gastroscopy. Secondary Objective: To evaluate the efficacy of different oral doses of KJ101 prior to gastroscopy in improving endoscopic visualization and to explore the Phase II recommended dose (RP2D) and immunogenicity. Phase II Trial Primary Objective: To evaluate the efficacy of different oral doses of KJ101 prior to gastroscopy in improving endoscopic visualization. Secondary Objective: To evaluate the safety, tolerability, and immunogenicity of a single oral dose of KJ101 in participants undergoing gastroscopy.

Start Date26 May 2026

Sponsor / Collaborator

Shanghai Bao Pharmaceutical Co. Ltd.

NCT07025408

/ RecruitingPhase 2

A Multicentre, Randomised, Double-blind, Dose-exploratory, Controlled Drug and Placebo-controlled Phase II Clinical Trial Evaluating the Safety, Efficacy, Pharmacokinetic Profile, and Immunogenicity of KJ101 for Wound Debridement in Deep II Degree Burns

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.

Start Date16 Jun 2025

Sponsor / Collaborator

Shanghai Bao Pharmaceutical Co. Ltd.

100 Clinical Results associated with KJ-101(Shanghai Bao Phaemaceuticals)

100 Translational Medicine associated with KJ-101(Shanghai Bao Phaemaceuticals)

100 Patents (Medical) associated with KJ-101(Shanghai Bao Phaemaceuticals)

100 Deals associated with KJ-101(Shanghai Bao Phaemaceuticals)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Burns	Phase 2	China	Shanghai Bao Pharmaceutical Co. Ltd.	16 Jun 2025
Stomach Diseases	IND Approval	China	Shanghai Bao Pharmaceutical Co. Ltd.	13 Mar 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis