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

Oriplantee Company Limited15 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hanoi Medical University

Hanoi, Hanoi, Vietnam

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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