A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability … (NCT07300202) | Clinical Trial Compass
CompletedPhase 1
A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers
Vietnam15 participantsStarted 2025-02-13
Plain-language summary
This Phase I clinical study is designed to evaluate the safety and determine the maximum tolerated dose (MTD) of Orialpha (BD-C) in healthy adult volunteers.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy male or female, aged 18 to 60 years.
. No clinically significant abnormalities in hematology, biochemistry, electrocardiogram (ECG), or vital signs as assessed by the investigator.
. Willing to voluntarily participate in the study by signing the informed consent form.
. Able to comply with study procedures and treatment as assessed by the investigator.
Exclusion criteria
. History of allergy to herbal-derived drugs similar to the investigational product or any excipient.
. Current or prior participation in another clinical trial involving an investigational product within the past 4 months.
. Use of immunosuppressive drugs within 28 days prior to the first dose of Orialpha.
. Active autoimmune disease or documented history of autoimmune disease within the past 2 years.
. History of primary immunodeficiency.
. Presence of any acute or chronic illness requiring treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute Number of Subjects Experiencing Treatment-related Adverse Events in Each Cohort
Timeframe: From the first dose administration until the final study visit (up to 90 days).
2
Absolute Number of Subjects Experiencing Adverse Events Leading to Study Discontinuation in Each Cohort
Timeframe: From the first dose administration until the final study visit (up to 90 days)
3
Absolute Number of Subjects Experiencing Serious Adverse Events (SAEs) in Each Cohort
Timeframe: From the first dose administration until the final study visit (up to 90 days).