CLINICAL RESEARCH PROTOCOL [A Phase I, Single-arm, Open-label, Dose-escalation Clinical Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers]
NCT ID: NCT07300202
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2025-02-13
2025-08-31
Brief Summary
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Detailed Description
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* Determine the frequency and severity of treatment-related adverse events, adverse events leading to discontinuation, and serious adverse events (SAEs) within each cohort.
* Assess the effects of Orialpha on hematology and biochemistry parameters before dosing and after the final dose in each cohort.
Healthy volunteers who meet all eligibility criteria will receive the investigational product for 7 days. The first cohort will include 3 participants receiving the lowest dose (0.25 × the anticipated clinical dose). Following safety evaluation, subsequent cohorts will receive higher dose levels (0.5 ×, 1.0 ×, 1.5 ×, and 2.0 × the anticipated clinical dose) according to predefined dose-escalation rules.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm - Orialpha (BD-C)
Participants in this single-arm, open-label, dose-escalation study will sequentially receive ascending doses of the investigational product Orialpha (BD-C) according to a traditional 3+3 design. The five planned dose levels are:
0.25× anticipated dose
0.5× anticipated dose
1. anticipated dose
1.5× anticipated dose
2. anticipated dose Safety and tolerability will be assessed after each cohort before escalating to the next dose level. All participants receive the investigational product; there is no comparator or placebo group.
Orialpha (BD-C)
Orialpha (BD-C) is a botanical investigational product derived from Uvaria grandiflora (Bù dẻ tía), with Zeylenone as its primary active compound. Participants will receive a single dose according to the assigned dose cohort. Safety, tolerability, and maximum tolerated dose (MTD) will be evaluated sequentially following the traditional 3+3 dose-escalation design.
Interventions
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Orialpha (BD-C)
Orialpha (BD-C) is a botanical investigational product derived from Uvaria grandiflora (Bù dẻ tía), with Zeylenone as its primary active compound. Participants will receive a single dose according to the assigned dose cohort. Safety, tolerability, and maximum tolerated dose (MTD) will be evaluated sequentially following the traditional 3+3 dose-escalation design.
Eligibility Criteria
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Inclusion Criteria
2. No clinically significant abnormalities in hematology, biochemistry, electrocardiogram (ECG), or vital signs as assessed by the investigator.
3. Willing to voluntarily participate in the study by signing the informed consent form.
4. Able to comply with study procedures and treatment as assessed by the investigator.
Exclusion Criteria
2. Current or prior participation in another clinical trial involving an investigational product within the past 4 months.
3. Use of immunosuppressive drugs within 28 days prior to the first dose of Orialpha.
4. Active autoimmune disease or documented history of autoimmune disease within the past 2 years.
5. History of primary immunodeficiency.
6. Presence of any acute or chronic illness requiring treatment.
7. Inability to comply with study procedures or investigational product administration as assessed by the investigator.
8. Female subjects who are pregnant or breastfeeding, or male or female subjects of reproductive potential not using effective contraception.
9. Any condition which, in the opinion of the investigator, would interfere with the evaluation of the investigational treatment, patient safety, or interpretation of study results
18 Years
60 Years
ALL
Yes
Sponsors
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Vietstar Biomedical Research
INDUSTRY
Oriplantee Company Limited
OTHER
Responsible Party
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Locations
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Hanoi Medical University
Hanoi, Hanoi, Vietnam
Countries
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Other Identifiers
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ORIPLANTEE
Identifier Type: -
Identifier Source: org_study_id