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CLINICAL RESEARCH PROTOCOL [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]

NCT07300202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-23

No results posted yet for this study

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.

Conditions

  • Evaluate the Safety Profile and Tolerability of Orialpha in Healthy Adult Volunteers
  • Breast Cancer

Interventions

DRUG

Orialpha (BD-C)

Orialpha (BD-C) is a botanical investigational product derived from Uvaria grandiflora (Bù dẻ tía), with Zeylenone as its primary active compound. Participants will receive a single dose according to the assigned dose cohort. Safety, tolerability, and maximum tolerated dose (MTD) will be evaluated sequentially following the traditional 3+3 dose-escalation design.

Sponsors & Collaborators

  • Vietstar Biomedical Research

    collaborator INDUSTRY

  • Oriplantee Company Limited

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2025-06-16
Completion
2025-08-31

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300202 on ClinicalTrials.gov