A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This Phase I, single-arm, open-label, dose-escalation clinical study is designed to evaluate the safety and determine the maximum tolerated dose (MTD) of Orialpha (BD-C) in healthy adult volunteers. The study aims to:
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Hanoi
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Hanoi, Hanoi, Vietnam, 100000
- Hanoi Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
- Inability to comply with study procedures or investigational product administration as assessed by the investigator.
- Female subjects who are pregnant or breastfeeding, or male or female subjects of reproductive potential not using effective contraception.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dose level 1
Subjects received Orialpha 1 sachet, strength 1.5 g/sachet q.d. for 7 consecutive days as part of a Phase I dose-escalation study. The first cohort of 03 participants will be enrolled and administered the lowest dose level. If no toxicity cases are observed, a subsequent cohort of 03 participants will receive the next dose level. If one toxicity case occurs at this dose in the first cohort of 03 participants, an additional 03 subjects will be enrolled and administered the same dose. If, among these 06 participants, only one toxicity case is observed, the second dose level will be tested. If two or more toxicity cases are observed among these 06 participants, the study will be terminated. This procedure will be repeated for the subsequent dose levels. |
Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Once daily
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Experimental: Dose level 2
Subjects received Orialpha 1 sachet, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study.
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Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
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Experimental: Dose level 3 (anticipated therapeutic dose)
Subjects received Orialpha 2 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study.
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Dosage: 2 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
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Experimental: Dose level 4
Subjects received Orialpha 3 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study
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Dosage: 3 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
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Experimental: Dose level 5
Subjects received Orialpha 4 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study
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Dosage: 4 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute Number of Subjects Experiencing Treatment-related Adverse Events in Each Cohort
Time Frame: From the first dose administration until the final study visit (up to 90 days).
|
Treatment-related adverse events were defined as adverse events assessed by the investigator as having a causal relationship with the investigational product (definite, probable, possible, or unlikely).
Results are presented as the absolute number of participants experiencing at least one treatment-related adverse event within each dose cohort.
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From the first dose administration until the final study visit (up to 90 days).
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Absolute Number of Subjects Experiencing Adverse Events Leading to Study Discontinuation in Each Cohort
Time Frame: From the first dose administration until the final study visit (up to 90 days)
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Adverse events leading to study discontinuation were defined as any adverse event that resulted in permanent discontinuation of study treatment, as assessed by the investigator.
Results are presented as the absolute number of participants experiencing at least one adverse event leading to study discontinuation within each dose cohort.
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From the first dose administration until the final study visit (up to 90 days)
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Absolute Number of Subjects Experiencing Serious Adverse Events (SAEs) in Each Cohort
Time Frame: From the first dose administration until the final study visit (up to 90 days).
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Serious adverse events (SAEs) were defined in accordance with ICH E2A criteria.
Results are presented as the absolute number of participants experiencing at least one serious adverse event within each dose cohort.
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From the first dose administration until the final study visit (up to 90 days).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Any Changes in Biochemical and Hematological Laboratory Parameters Before and After Treatment Were Assessed to Evaluate Safety
Time Frame: Compared between Screening Visit (V0) and End of Treatment Visit (V2), approximately 7 days apart
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Hematological and biochemical parameters at the end of the study were assessed, including: red blood cells (RBC), white blood cells (WBC), platelets, hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine The variables will be presented in a shift table with three categories: "normal," "abnormal - not clinically significant," and "abnormal - clinically significant" at both pre-study and post-study time points. A summary of laboratory parameters will be described in accordance with US FDA requirements. |
Compared between Screening Visit (V0) and End of Treatment Visit (V2), approximately 7 days apart
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORIPLANTEE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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