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A Phase I, Single-arm, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Orialpha (BD-C) in Healthy Adult Volunteers
Sponsor: Oriplantee Company Limited
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.
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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-02-13
Completion Date
2025-08-31
Last Updated
2026-07-16
Healthy Volunteers
Yes
Conditions
Interventions
Orialpha (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
Orialpha (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
Orialpha (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
Orialpha (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
Orialpha (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
Locations (1)
Hanoi Medical University
Hanoi, Hanoi, Vietnam