Ulcerative Colitis (UC)Phase 1NCT07632573
A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult
A Phase 1 study testing BDHK-2009 Tablets in people with Ulcerative Colitis (UC) and Ulcerative Colitis (Disorder), run by Benethera (Shaoxing) Biotechnology Co., Ltd. at 1 site in China.
Trial summary
A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis (UC), Ulcerative Colitis (Disorder), Ulcerative Colitis Acute
- What is being tested?
- BDHK-2009 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to 28 Feb 2027
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Participants who are able to communicate effectively with the investigator, understand and comply with the trial requirements, voluntarily participate in the trial, and understand and sign the informed consent form.
- 2. Healthy participants aged 18 to 55 years (inclusive), regardless of gender. 3. Weight ≥ 50 kg (for males) and ≥ 45 kg (for females), with a body mass index (BMI) of 18-26 kg/m².
- 4. At screening, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, serological virology, thyroid function, etc.) results are either within normal limits or, if abnormal, not clinically significant.
- 5. Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening and baseline, and must not be pregnant, lactating, or planning pregnancy during the study period. WOCBP must agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product (whichever is longer).
- WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal;
- Non-childbearing potential females are defined as postmenopausal females and premenopausal females who have undergone sterilization surgery. Postmenopausal is defined as the absence of menstruation for ≥ 12 months without alternative medical intervention. Follicle-stimulating hormone (FSH) testing will be performed for subjects with uncertain status, and FSH > 40 mIU/mL can confirm menopause.
- 6. Male participants with partners of childbearing potential are eligible for the study only if they agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product, and agree not to donate sperm during this period. In addition, male participants with partners of childbearing potential must use condoms continuously until at least 90 days after the last dose of the investigational product (whichever is longer).
Who cannot join
- 1. As determined by the investigator, known or persistent psychiatric disorders requiring pharmacological intervention that may interfere with the participant's participation in the study, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder.
- 2. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, psychiatric, thyroid, or other disorders, as determined by the investigator to be unsuitable for participation in this study.
- 3. Presence or suspected presence of active viral, bacterial, fungal, or parasitic infection.
- 4. History of recurrent or chronic infections.
- 5. Participants with acute illness within 2 weeks prior to screening; participants with clinically significant infections (e.g., upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.) within 3 months prior to screening; participants with evidence of any infection within 7 days prior to screening; participants with a history of herpes simplex infection or recurrent (>1 episode) herpes zoster or disseminated herpes zoster.
- 6. History of epidemic meningococcal infection.
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- 7. History of splenectomy or functional asplenia.
- 8. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody.
- 9. Participants with a history of active tuberculosis or evidence of active or latent tuberculosis infection at screening.
- 10. Participants with a history of allergic tendencies, such as asthma, atopic dermatitis, chronic urticaria, or allergic rhinitis, or with allergies to two or more medications, foods, or pollens; participants with a history of hypersensitivity to the investigational drug or any of its components or to drugs with the same mechanism of action, or with clinically significant allergy history as determined by the investigator to be ineligible for enrollment.
- 11. Participants who have participated in another interventional clinical study and received an interventional treatment (including investigational drugs and investigational medical devices) within 30 days prior to the first dose of the study drug, or within 5 half-lives of the study drug (whichever is longer).
- 12. Participants with a history of drug abuse within 12 months prior to screening, or participants with positive urine drug screening results.
- 13. Participants who have used any strong inducers or strong inhibitors of the hepatic metabolic enzyme CYP3A within 14 days or 5 half-lives prior to administration of the investigational drug (whichever is longer).
- 14. Participants who have used any prescription medications within 14 days prior to administration of the investigational drug, or any over-the-counter medications, herbal medicines, or dietary supplements within 7 days prior to administration of the investigational drug, unless the investigator determines that the medication is not clinically significant.
- 15. Participants who have consumed any foods or beverages containing substances that may induce or inhibit hepatic metabolic enzymes (such as grapefruit, Seville orange, or star fruit, etc.) within 7 days prior to administration of the investigational drug, or who are unable to avoid consumption of foods or beverages containing caffeine within 48 hours prior to administration of the investigational drug and throughout the inpatient study period.
- 16. Participants who consumed more than 14 units of alcohol per week within 1 month prior to screening (1 unit of alcohol is approximately equivalent to 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), or who consumed any alcohol products within 24 hours prior to dosing, or who have positive alcohol screening test results.
- 17. Heavy smokers or participants who smoked more than 5 cigarettes per day within 3 months prior to dosing, and who are unable to abstain from using more than 5 tobacco or nicotine-containing products (including nicotine patches) per week from screening through the end of the study.
- 18. Participants who donated blood or experienced blood loss ≥ 200 mL within 1 month prior to screening or dosing, or who donated blood or experienced blood loss ≥ 400 mL within 3 months prior to dosing, or who have difficult venous access or are unable to tolerate blood sampling.
- 19. At screening or baseline, 12-lead electrocardiogram (ECG) findings showing clinically significant abnormalities, including but not limited to: QTcF > 450 ms, or other arrhythmias or morphological abnormalities as determined by the investigator that may increase participant risk or interfere with data interpretation.
- 20. Participants with dysphagia or special dietary requirements who are unable to accept a standardized diet (e.g., severe food allergies).
- 21. Participants who have undergone major surgical procedures within 3 months prior to screening or who are planning to undergo surgery during the trial period.
- 22. Participants who have received vaccination within 8 weeks prior to screening, or who plan to receive vaccination during the study or within 8 weeks after administration of the study drug.
- 23. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, 311200
Jinliang Chen, +86-0571-82905276, kingbright10@126.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics of BDHK-2009 Tablets in Healthy Adult Participants: a Randomized, Double-blind, Placebo-controlled, Single-dose/Multiple-dose Escalation Study.
A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.
- Conditions
- Ulcerative Colitis (UC), Ulcerative Colitis (Disorder), Ulcerative Colitis Acute, IBD (Inflammatory Bowel Disease), CD - Crohn's Disease
- Being tested
- BDHK-2009 Tablets, Placebo
- Keywords
- Crohn's disease, Ulcerative Colitis, Inflammatory Bowel Disease, IBD, CD, UC
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDHK-2009 TabletsDrug
Administration: Oral
PlaceboDrug
Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| BDHK-2009 Tablets | Experimental | SAD1-6: Participants will be randomized to receive either single dose of BDHK-2009 Tablets.
SAD 4 will be double blinded cross-over period is to determine food effect and participants will receive BDHK2009 Tablets under fed conditions in the second period.
MAD is repeat ascending dose sequential period. There will three cohortsof 8 healthy subjects. In each cohort subjects will be randomized to receive BDHK-2009 Tablets or Placebo in ratio 3:1. Subjects will receive BDHK-2009 Tablets QD. Receives: Drug: BDHK-2009 Tablets |
| Placebo | Placebo comparator | SAD1-6: Participants will be randomized to receive either single dose of Placebo.
SAD 4 will be double blinded cross-over period is to determine food effect and participants will receive Placebo under fed conditions in the second period.
MAD is repeat ascending dose sequential period. There will three cohortsof 8 healthy subjects. In each cohort subjects will be randomized to receive BDHK-2009 Tablets or Placebo in ratio 3:1. Subjects will receive Placebo QD. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of a single dose/multiple doses of BDHK-2009 in healthy participants.
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 6.0 including clinical significant changes in safety laboratory, vital signs, 12-lead ECG, and physical examination
Measured: From enrollment to the end of treatment at week 4.
Secondary outcomes (9)
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Peak plasma Concentration (Cmax)
Measured: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple dose of BDHK-2009 in healthy participants.
Area under the drug concentration-time curve (AUC)
Measured: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple dose of BDHK-2009 in healthy participants.
Time to maximum observed concentration (Tmax)
Measured: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Terminal half-life (t½)
Measured: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Total plasma clearance of drug (CL/F)
Measured: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Volume of distribution after oral administration (Vz/F)
Measured: From enrollment to the end of treatment at week 4.
To evaluate the pharmacodynamics (PD) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Change from baseline of cytokines levels
Measured: From enrollment to the end of treatment at week 4
To evaluate the effect of a high fat meal on the pharmacokinetics (PK) of a single dose of BDHK-2009 in healthy participants.
Peak plasma Concentration (Cmax)
Measured: From enrollment to the end of treatment at week 4.
To evaluate the effect of a high fat meal on the pharmacokinetics (PK) of a single dose of BDHK-2009 in healthy participants.
Area under the drug concentration-time curve (AUC)
Measured: From enrollment to the end of treatment at week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start18 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benethera (Shaoxing) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jinliang Chen, Principal investigator, Zhejiang Xiaoshan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632573
- Sponsor's protocol ID
- BDHK-2009-001
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics of BDHK-2009 Tablets in Healthy Adult Participants: a Randomized, Double-blind, Placebo-controlled, Single-dose/Multiple-dose Escalation Study.
- ClinicalTrials.gov ID
- NCT07632573
- Acronym / sponsor ID
- BDHK-2009-001
- Conditions
- Ulcerative Colitis (UC), Ulcerative Colitis (Disorder), Ulcerative Colitis Acute, IBD (Inflammatory Bowel Disease), CD - Crohn's Disease
- Keywords
- Crohn's disease, Ulcerative Colitis, Inflammatory Bowel Disease, IBD, CD, UC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Benethera (Shaoxing) Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 8 Jun 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.
A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BDHK-2009 Tablets | Experimental | Drug: BDHK-2009 TabletsSAD1-6: Participants will be randomized to receive either single dose of BDHK-2009 Tablets. SAD 4 will be double blinded cross-over period is to determine food effect and participants will receive BDHK2009 Tablets under fed conditions in the second period. MAD is repeat ascending dose sequential period. There will three cohortsof 8 healthy subjects. In each cohort subjects will be randomized to receive BDHK-2009 Tablets or Placebo in ratio 3:1. Subjects will receive BDHK-2009 Tablets QD. |
| Placebo | Placebo comparator | Drug: PlaceboSAD1-6: Participants will be randomized to receive either single dose of Placebo. SAD 4 will be double blinded cross-over period is to determine food effect and participants will receive Placebo under fed conditions in the second period. MAD is repeat ascending dose sequential period. There will three cohortsof 8 healthy subjects. In each cohort subjects will be randomized to receive BDHK-2009 Tablets or Placebo in ratio 3:1. Subjects will receive Placebo QD. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Participants who are able to communicate effectively with the investigator, understand and comply with the trial requirements, voluntarily participate in the trial, and understand and sign the informed consent form.
- 2. Healthy participants aged 18 to 55 years (inclusive), regardless of gender. 3. Weight ≥ 50 kg (for males) and ≥ 45 kg (for females), with a body mass index (BMI) of 18-26 kg/m².
- 4. At screening, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, serological virology, thyroid function, etc.) results are either within normal limits or, if abnormal, not clinically significant.
- 5. Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening and baseline, and must not be pregnant, lactating, or planning pregnancy during the study period. WOCBP must agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product (whichever is longer).
- WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal;
Key exclusion criteria (23 listed)
- 2. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, psychiatric, thyroid, or other disorders, as determined by the investigator to be unsuitable for participation in this study.
- 3. Presence or suspected presence of active viral, bacterial, fungal, or parasitic infection.
- 4. History of recurrent or chronic infections.
- 5. Participants with acute illness within 2 weeks prior to screening; participants with clinically significant infections (e.g., upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.) within 3 months prior to screening; participants with evidence of any infection within 7 days prior to screening; participants with a history of herpes simplex infection or recurrent (>1 episode) herpes zoster or disseminated herpes zoster.
- 6. History of epidemic meningococcal infection.
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 |
|---|---|---|
| BDHK-2009 TabletsAdministration: Oral | Drug | BDHK-2009 Tablets |
| PlaceboAdministration: Oral | Drug | Placebo |
Primary outcome
To evaluate the safety and tolerability of a single dose/multiple doses of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 6.0 including clinical significant changes in safety laboratory, vital signs, 12-lead ECG, and physical examination
9 secondary outcomes
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple dose of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple dose of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
To evaluate the pharmacodynamics (PD) of a single dose/multiple doses of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4
To evaluate the effect of a high fat meal on the pharmacokinetics (PK) of a single dose of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
To evaluate the effect of a high fat meal on the pharmacokinetics (PK) of a single dose of BDHK-2009 in healthy participants.
Time frame: From enrollment to the end of treatment at week 4.
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 8 Jun 2026.
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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.
Jinliang Chen principal investigator
Zhejiang Xiaoshan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BDHK-2009 Tablets in people with Ulcerative Colitis (UC) and Ulcerative Colitis (Disorder), run by Benethera (Shaoxing) Biotechnology Co., Ltd. at 1 site in China.
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 7 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Shuang Zhang (+86-010-82146616, zhangshuang@benethera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of a single dose/multiple doses of BDHK-2009 in healthy participants. (time frame: From enrollment to the end of treatment at week 4.). 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 8 Jun 2026.