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]

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Evaluate the Safety Profile and Tolerability of Orialpha in Healthy Adult Volunteers
• Intervention / Treatment: Drug: Orialpha (BD-C)

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: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi
    • Hanoi, Hanoi, Vietnam, 100000
      • Hanoi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female, aged 18 to 60 years.
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:

1. History of allergy to herbal-derived drugs similar to the investigational product or any excipient.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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; anticipated dose1.5× anticipated dose; 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.

Drug: 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.

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	Percentage (%) is calculated as the absolute number of treatment-related adverse events divided by the total number of subjects in the SS.	From the first dose administration until the final study visit (up to 90 days).
Absolute number of subjects experiencing adverse events leading to study discontinuation in each cohort	Percentage (%) is calculated as the absolute number of adverse events leading to discontinuation divided by the total number of subjects in the SS.	From the first dose administration until the final study visit (up to 90 days)
Absolute number of subjects experiencing serious adverse events (SAEs) in each cohort	Percentage (%) is calculated as the absolute number of SAEs divided by the total number of subjects in the SS	From the first dose administration until the final study visit (up to 90 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemistry and hematology test values (quantitative variables) before and after the study	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

Collaborators and Investigators

• Sponsor: Oriplantee Company Limited
• Collaborators: Vietstar Biomedical Research

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; phase 1; Orialpha
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: ORIPLANTEE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No