Breast Cancer
Conditions
Keywords
Orialpha, breast cancer, phase 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.
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.
Interventions
DRUGOrialpha (BD-C) at 0.25 x anticipated therapeutic dose
Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Once daily
DRUGOrialpha (BD-C) at 0.5 x anticipated therapeutic dose
Dosage: 1 sachet, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
DRUGOrialpha (BD-C) at the anticipated therapeutic dose
Dosage: 2 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
DRUGOrialpha (BD-C) at 1.5 x anticipated therapeutic dose
Dosage: 3 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
DRUGOrialpha (BD-C) at 2 x anticipated therapeutic dose
Dosage: 4 sachets, strength 1.5 g/sachet Dosage form: Powder for oral suspension (sachet) Frequency of administration: Twice daily for 7 consecutive days
Sponsors
Oriplantee Company Limited
Vietstar Biomedical Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Number of Subjects Experiencing Treatment-related Adverse Events in Each Cohort | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
Vietnam
Participant flow
Recruitment details
A total of 20 healthy adult volunteers were screened at the Clinical Pharmacology Center, Hanoi Medical University. One subject failed screening due to clinically significant hypertension, and four subjects declined participation prior to study drug administration. Fifteen subjects were enrolled sequentially into five dose-escalation cohorts (3 subjects per cohort). All enrolled subjects received at least one dose of Orialpha and completed the study through the Day 90 follow-up visit.
Pre-assignment details
This was a non-randomized, open-label, single-arm, Phase I dose-escalation study using a traditional 3+3 design. Eligible subjects were enrolled sequentially and assigned to dose cohorts starting from the lowest dose level (0.25× anticipated clinical dose). Escalation to higher dose levels (0.5×, 1.0×, 1.5×, and 2.0× anticipated therapeutic dose) was based on safety evaluation of the preceding cohort. No randomization or blinding was applied.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 20 years old STANDARD_DEVIATION 0 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
| The number of participants with medical history | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
None listed