A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers

NCT07300202 | Completed Phase 1 Results 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

Keywords

Orialpha; breast cancer; phase 1

Outcome Measures

Primary Outcomes (3)

• Absolute Number of Subjects Experiencing Treatment-related Adverse Events in Each Cohort

  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.

  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

  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.

  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

  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.

  From the first dose administration until the final study visit (up to 90 days).

Secondary Outcomes (1)

• Number of Participants With Any Changes in Biochemical and Hematological Laboratory Parameters Before and After Treatment Were Assessed to Evaluate Safety

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

Study Arms (5)

Dose level 1

EXPERIMENTAL

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.

Drug: Orialpha (BD-C) at 0.25 x anticipated therapeutic dose

Dose level 2

EXPERIMENTAL

Subjects received Orialpha 1 sachet, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study.

Drug: Orialpha (BD-C) at 0.5 x anticipated therapeutic dose

Dose level 3 (anticipated therapeutic dose)

EXPERIMENTAL

Subjects received Orialpha 2 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study.

Drug: Orialpha (BD-C) at the anticipated therapeutic dose

Dose level 4

EXPERIMENTAL

Subjects received Orialpha 3 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study

Drug: Orialpha (BD-C) at 1.5 x anticipated therapeutic dose

Dose level 5

EXPERIMENTAL

Subjects received Orialpha 4 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study

Drug: Orialpha (BD-C) at 2 x anticipated therapeutic dose

Interventions

Orialpha (BD-C) at 0.25 x anticipated therapeutic dose DRUG

Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Once daily

Dose level 1

Orialpha (BD-C) at 0.5 x anticipated therapeutic dose DRUG

Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days

Dose level 2

Orialpha (BD-C) at the anticipated therapeutic dose DRUG

Dosage: 2 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days

Dose level 3 (anticipated therapeutic dose)

Orialpha (BD-C) at 1.5 x anticipated therapeutic dose DRUG

Dosage: 3 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days

Dose level 4

Orialpha (BD-C) at 2 x anticipated therapeutic dose DRUG

Dosage: 4 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days

Dose level 5

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

Limitations and Caveats

This study was a Phase 1, single-arm, open-label trial with a small sample size typical of first-in-human dose-escalation studies. The study was conducted in healthy adult volunteers and was not designed to assess efficacy or long-term safety. Therefore, the results may not be generalizable to patient populations or predictive of clinical efficacy.

Results Point of Contact

• Title: Sponsor
• Organization: ORIPLANTEE Company Limited

hoai77@gmail.com

+84 914 019 691

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• 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: SEQUENTIAL
• 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: July 16, 2026
• Results First Posted: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)