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New treatment option for Ulcerative Colitis
Official title A Study of Single and Multiple Ascending Doses of H021 in Healthy Participants
ClinicalTrials.gov ID: NCT06627556
What this study is testing
What is H021?
H021 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis.
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
- The primary purpose of this study is to evaluate the safety and tolerability of H021 tablets following oral administration of single and multiple ascending doses in healthy 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
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than and equal to (\>=) 18 and less...
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric...
- Female participants of non-childbearing potential must be:
You likely can't join if
- Any clinically significant abnormal finding at physical examination.
- Clinically significant abnormal laboratory test results including biochemistry, hematology, urinalysis, and coagulation results, or positive serology...
- Positive pregnancy test or lactating female participant.
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
- History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
- Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimetres of mercury...
See the full eligibility criteria
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), greater than and equal to (\>=) 18 and less than and equal to (\ )18.5 and less than (\<) 32.0 kilograms per square...
- Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Female participants of non-childbearing potential must be:
- post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle-stimulating hormone (FSH) levels \>=40 milli-international units per milliliter (mIU/mL); or
- surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal occlusion) at least 3 months prior to dosing.
- Participants must be willing not to donate sperm for 90 days or ova (egg) for 6 months after the last dose.
- Sexually active females of childbearing potential and non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
- Able to understand the study procedures and provide signed informed consent to participate in the study.
- Any clinically significant abnormal finding at physical examination.
- Clinically significant abnormal laboratory test results including biochemistry, hematology, urinalysis, and coagulation results, or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C...
- Positive pregnancy test or lactating female participant.
- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or Day -1.
- History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
- Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 millimetres of mercury (mmHg), diastolic blood pressure lower than 40 or over 90 mmHg, heart rate...
- History of drug abuse within 1 year prior to screening as determined by the investigator.
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 1 month prior to screening that exceeds 10 units of alcohol per week for women and men (1 unit = 375 [milliliter] mL of beer...
- History of active tuberculosis or presence of active or latent tuberculosis. Previous latent tuberculosis that has been treated and is no longer active is not exclusionary.
- History of clinically significant opportunistic infection (example, invasive candidiasis or pneumocystis pneumonia).
- History of serious local infection (example, cellulitis, abscess) or systemic infection (example, septicemia) within 3 months prior to screening.
- Presence of fever (body temperature greater than (\>) 37.5 degrees Celsius (°C) (example, a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to dosing.
- Use of medications within the timeframes specified.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of...
- Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
- Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Melbourne, Victoria, Australia. 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.