Gastric Mucosal LesionPhase 2NCT07893600
Efficacy and Safety of OsrhCT Before Upper Endoscopy on Improving Visualization of the Gastric Mucosa.
A Phase 2 study testing Recombinant Human Chymotrypsin(OsrhCT) 4000U in people with Gastric Mucosal Lesion, run by Healthgen Biotechnology Corp..
Trial summary
Study was designed to evaluate efficacy and safety of OsrhCT before upper endoscopy on visibility of gastric mucosa. A total of 40 subjects (both male and female) are expected to be enrolled in this trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Mucosal Lesion
- What is being tested?
- Recombinant Human Chymotrypsin(OsrhCT) 4000U
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 27 Oct 2026to 22 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients clinically indicated for gastroscopy examination;
- Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent;
- Able to complete the research according to the requirements of the experimental plan;
- Subjects (including their spouses) voluntarily have no pregnancy plans and use contraception during the study and within 3 months after the last administration of the study drug;
- Aged 18-75 years (inclusive), male or female;
Who cannot join
- Known to be allergic to any preparation or anesthesia medication before gastroscopy examination;
- Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc;
- Subjects disabled to stand sedation anesthesia or gastroscopy examination;
- Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices;
- Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery;
- Subjects with a positive result for any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), or Treponema pallidum antibody.
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- Abnormal laboratory values:: alanine aminotransferase (ALT)>2 × ULN, aspartate aminotransferase (AST)>2 × ULN, serum creatinine>1.5 × ULN;
- Difficult venous access, inability to tolerate venipuncture for blood collection, or a history of blood- or needle-induced syncope.
- Female subjects who had unprotected sex within 14 days prior to screening; Pregnant or breastfeeding women, or who have a positive serum β-HCG test.
- Subjects who have participated in any drug clinical trial and received treatment within the last 3 months;
- Any other conditions deemed unsuitable for the study by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Zhenzhen Zhou, MD contact
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Oral Recombinant Human Chymotrypsin Lyophilized Powder in Improving Mucosal Visualization Clarity During Gastroscopy
Study was designed to evaluate efficacy and safety of OsrhCT before upper endoscopy on visibility of gastric mucosa.
A total of 40 subjects (both male and female) are expected to be enrolled in this trial.
Read the detailed description
This is a single-center, double-blind, randomized study involving 40 patients indicated for diagnostic upper endoscopy. Patients were randomly assigned to one of two arms, with OsrhCT 12000U and matching placebo. The total visibility score was given by the sum of the score 1-4 evaluated for lower esophagus, gastric fundus, upper gastric body, lower gastric body, gastric antrum subsequently by two or three blinded endoscopists. Other parameters monitored were examination time, the amount of water flushed for satisfactory observation of the upper gastrointestinal tract, and incidence of adverse events
- Conditions
- Gastric Mucosal Lesion
- Being tested
- Recombinant Human Chymotrypsin(OsrhCT) 4000U, Placebo for Recombinant Human Chymotrypsin(OsrhCT)
- Keywords
- OsrhCT, Recombinant Human Chymotrypsin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Chymotrypsin(OsrhCT) 4000UDrug
Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/bag, freeze-dried powder
Placebo for Recombinant Human Chymotrypsin(OsrhCT)Drug
Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 0 U/bag, freeze-dried powder
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Chymotrypsin(OsrhCT) 12000U | Experimental | Recombinant Human Chymotrypsin(OsrhCT) 4000U/bag *3 bags Receives: Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000U |
| Placebo for Recombinant Human Chymotrypsin(OsrhCT) | Placebo comparator | Placebo for Recombinant Human Chymotrypsin(OsrhCT) 0U/bag *3 bags Receives: Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total visibility score (TVS) evaluated by blinded endoscopists
"Total visibility score"counted as the sum of visibility score in lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum.
Measured: Through study completion, up to 2 months
Secondary outcomes (4)
Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach
Vsibility scores for the lower esophagus, antrum, lower gastric body, upper gastric body, and fundus.
Measured: Through study completion, up to 2 months
The amount of water flushed for satisfactory observation of the upper gastrointestinal tract
Amount of water used to allow an suitable visualization of gastric mucosa
Measured: During diagnostic upper endoscopy, up to 1 hour
Duration of endoscopy
Time to complete the upper endoscopy (from the time of oral intubation until complete removal of the endoscope)
Measured: During diagnostic upper endoscopy, up to 1 hour
Incidence of adverse events
Number of gastroscopy procedures with adverse event divided by the number of all gastroscopy procedures. Number of participants with treatment-related adverse events as assessed by CTCAE V6.0.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start27 Oct 2026 (estimated)
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Mucosal LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthgen Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mei Liu, MD, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893600
- Sponsor's protocol ID
- HY1005-1-2026-P2-T
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Oral Recombinant Human Chymotrypsin Lyophilized Powder in Improving Mucosal Visualization Clarity During Gastroscopy
- ClinicalTrials.gov ID
- NCT07893600
- Acronym / sponsor ID
- HY1005-1-2026-P2-T
- Conditions
- Gastric Mucosal Lesion
- Keywords
- OsrhCT, Recombinant Human Chymotrypsin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Healthgen Biotechnology Corp.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2026 (estimated)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study was designed to evaluate efficacy and safety of OsrhCT before upper endoscopy on visibility of gastric mucosa.
A total of 40 subjects (both male and female) are expected to be enrolled in this trial.
Detailed description
This is a single-center, double-blind, randomized study involving 40 patients indicated for diagnostic upper endoscopy. Patients were randomly assigned to one of two arms, with OsrhCT 12000U and matching placebo. The total visibility score was given by the sum of the score 1-4 evaluated for lower esophagus, gastric fundus, upper gastric body, lower gastric body, gastric antrum subsequently by two or three blinded endoscopists. Other parameters monitored were examination time, the amount of water flushed for satisfactory observation of the upper gastrointestinal tract, and incidence of adverse events
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Chymotrypsin(OsrhCT) 12000U | Experimental | Drug: Recombinant Human Chymotrypsin(OsrhCT) 4000URecombinant Human Chymotrypsin(OsrhCT) 4000U/bag *3 bags |
| Placebo for Recombinant Human Chymotrypsin(OsrhCT) | Placebo comparator | Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT)Placebo for Recombinant Human Chymotrypsin(OsrhCT) 0U/bag *3 bags |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients clinically indicated for gastroscopy examination;
- Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent;
- Able to complete the research according to the requirements of the experimental plan;
- Subjects (including their spouses) voluntarily have no pregnancy plans and use contraception during the study and within 3 months after the last administration of the study drug;
- Aged 18-75 years (inclusive), male or female;
Key exclusion criteria (11 listed)
- Known to be allergic to any preparation or anesthesia medication before gastroscopy examination;
- Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc;
- Subjects disabled to stand sedation anesthesia or gastroscopy examination;
- Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices;
- Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Chymotrypsin(OsrhCT) 4000URecombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/bag, freeze-dried powder | Drug | Recombinant Human Chymotrypsin(OsrhCT) 12000U |
| Placebo for Recombinant Human Chymotrypsin(OsrhCT)Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 0 U/bag, freeze-dried powder | Drug | Placebo for Recombinant Human Chymotrypsin(OsrhCT) |
Primary outcome
Total visibility score (TVS) evaluated by blinded endoscopists
Time frame: Through study completion, up to 2 months
"Total visibility score"counted as the sum of visibility score in lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum.
4 secondary outcomes
Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach
Time frame: Through study completion, up to 2 months
The amount of water flushed for satisfactory observation of the upper gastrointestinal tract
Time frame: During diagnostic upper endoscopy, up to 1 hour
Duration of endoscopy
Time frame: During diagnostic upper endoscopy, up to 1 hour
Incidence of adverse events
Time frame: up to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenzhen Zhou, MD contact
Mei Liu, MD principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Chymotrypsin(OsrhCT) 4000U in people with Gastric Mucosal Lesion, run by Healthgen Biotechnology Corp..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Liu, MD (+8618627714881, 1744634750@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total visibility score (TVS) evaluated by blinded endoscopists (time frame: Through study completion, up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.