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Tests treatment safety and results for Ulcerative Colitis (UC)
Official title A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult
ClinicalTrials.gov ID: NCT07632573
What this study is testing
What is BDHK-2009 Tablets?
BDHK-2009 Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis (uc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- \- 1. Participants who are able to communicate effectively with the investigator, understand and comply with the trial requirements, voluntarily...
- WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and...
- Non-childbearing potential females are defined as postmenopausal females and premenopausal females who have undergone sterilization surgery...
You likely can't join if
- 1\. As determined by the investigator, known or persistent psychiatric disorders requiring pharmacological intervention that may interfere with the...
- 2\. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal...
- 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...
- 6\. History of epidemic meningococcal infection.
See the full eligibility criteria
- \- 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...
- 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...
- 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...
- 2\. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urinary...
- 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...
- 6\. History of epidemic meningococcal infection.
- 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...
- 11\. Participants who have participated in another treatment clinical study and received an treatment treatment (including investigational drugs and investigational medical devices) within 30 days prior to the first...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.