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COMPLETED
NCT07300202
PHASE1

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

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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