Breast CancerPhase 1NCT07300202
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 1 study testing Orialpha (BD-C) at 0.25 x anticipated therapeutic dose, Orialpha (BD-C) at 0.5 x anticipated therapeutic dose and Orialpha (BD-C) at the anticipated therapeutic dose in people with Breast Cancer, run by Oriplantee Company Limited at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Orialpha (BD-C) at 0.25 x anticipated therapeutic dose, Orialpha (BD-C) at 0.5 x anticipated therapeutic dose and Orialpha (BD-C) at the anticipated therapeutic dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Feb 2025to 31 Aug 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Orialpha (BD-C) at 0.25 x anticipated therapeutic dose, Orialpha (BD-C) at 0.5 x anticipated therapeutic dose, Orialpha (BD-C) at the anticipated therapeutic dose, Orialpha (BD-C) at 1.5 x anticipated therapeutic dose, Orialpha (BD-C) at 2 x anticipated therapeutic dose
- Keywords
- Orialpha, breast cancer, phase 1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orialpha (BD-C) at 0.25 x anticipated therapeutic doseDrug
Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Once daily
Orialpha (BD-C) at 0.5 x anticipated therapeutic doseDrug
Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
Orialpha (BD-C) at the anticipated therapeutic doseDrug
Dosage: 2 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
Orialpha (BD-C) at 1.5 x anticipated therapeutic doseDrug
Dosage: 3 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
Orialpha (BD-C) at 2 x anticipated therapeutic doseDrug
Dosage: 4 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: Drug: Orialpha (BD-C) at 2 x anticipated therapeutic dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Compared between Screening Visit (V0) and End of Treatment Visit (V2), approximately 7 days apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start13 Feb 2025
- Primary completion16 Jun 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oriplantee Company Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Vietstar Biomedical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300202
- Sponsor's protocol ID
- ORIPLANTEE
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2025
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07300202
- Acronym / sponsor ID
- ORIPLANTEE
- Conditions
- Breast Cancer
- Keywords
- Orialpha, breast cancer, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oriplantee Company LimitedUniversity, hospital or other
- Collaborators
- Vietstar Biomedical Research
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: Orialpha (BD-C) at 0.25 x anticipated therapeutic doseSubjects 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. |
| Dose level 2 | Experimental | Drug: Orialpha (BD-C) at 0.5 x anticipated therapeutic doseSubjects received Orialpha 1 sachet, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study. |
| Dose level 3 (anticipated therapeutic dose) | Experimental | Drug: Orialpha (BD-C) at the anticipated therapeutic doseSubjects received Orialpha 2 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study. |
| Dose level 4 | Experimental | Drug: Orialpha (BD-C) at 1.5 x anticipated therapeutic doseSubjects received Orialpha 3 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study |
| Dose level 5 | Experimental | Drug: Orialpha (BD-C) at 2 x anticipated therapeutic doseSubjects received Orialpha 4 sachets, strength 1.5 g/sachet BID for 7 consecutive days as part of a Phase I dose-escalation study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orialpha (BD-C) at 0.25 x anticipated therapeutic doseDosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Once daily | Drug | Dose level 1 |
| Orialpha (BD-C) at 0.5 x anticipated therapeutic doseDosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days | Drug | Dose level 2 |
| Orialpha (BD-C) at the anticipated therapeutic doseDosage: 2 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days | Drug | Dose level 3 (anticipated therapeutic dose) |
| Orialpha (BD-C) at 1.5 x anticipated therapeutic doseDosage: 3 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days | Drug | Dose level 4 |
| Orialpha (BD-C) at 2 x anticipated therapeutic doseDosage: 4 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days | Drug | Dose level 5 |
Primary outcome
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.
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)
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.
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).
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Orialpha (BD-C) at 0.25 x anticipated therapeutic dose, Orialpha (BD-C) at 0.5 x anticipated therapeutic dose and Orialpha (BD-C) at the anticipated therapeutic dose in people with Breast Cancer, run by Oriplantee Company Limited at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.