Trial Outcomes & Findings for A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers (NCT NCT07300202)

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.

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.

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

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.

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.

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.

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.