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]

NCT07300202 | Completed Phase 1 DMC

• 1 other identifier: ORIPLANTEE
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Evaluate the Safety Profile and Tolerability of Orialpha in Healthy Adult Volunteers

Keywords

Orialpha; breast cancer; phase 1

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Biochemistry and hematology test values (quantitative variables) before and after the study

  Compared between Screening Visit (V0) and End of Treatment Visit (V2), approximately 7 days apart

Study Arms (1)

Single Arm - Orialpha (BD-C)

EXPERIMENTAL

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.

Drug: Orialpha (BD-C)

Interventions

Orialpha (BD-C) DRUG

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.

Single Arm - Orialpha (BD-C)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oriplantee Company Limited: lead
• Vietstar Biomedical Research: collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No blinding is performed. This is an open-label study in which participants, investigators, and study staff are aware of the investigational product being administered.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, open-label, dose-escalation study using a traditional 3+3 design. Healthy adult volunteers will be enrolled sequentially into five ascending dose cohorts: 0.25×, 0.5×, 1×, 1.5×, and 2× the anticipated dose. Safety and tolerability will be assessed after each cohort prior to escalation to the next dose level. All participants will receive the investigational product, Orialpha (BD-C), and there is no comparator or placebo group

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: February 13, 2025
• Primary Completion: June 16, 2025
• Study Completion: August 31, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)