Botanical extract from vietnamese plant tested for safety in first human trial

NCT ID NCT07300202

Knowledge-focused Sponsor: Oriplantee Company Limited Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This early-stage study tested the safety of a single dose of Orialpha (BD-C), a drug made from the Uvaria grandiflora plant, in 15 healthy adults aged 18 to 60. Researchers monitored side effects and determined the highest safe dose. The study does not test whether the drug works against breast cancer, but it is a first step toward future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Orialpha (BD-C), a botanical extract from the Uvaria grandiflora plant
What this could lead to: If safe, this could pave the way for future studies testing Orialpha as a potential treatment for breast cancer.
What could go wrong: This is a very early Phase I safety study in only 15 healthy people. It does not test whether the drug works against cancer, and many early-stage drugs fail to show benefit later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

15 people

The number who actually took part.

Started

Feb 2025

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Evaluate the safety profile and tolerability of orialpha in healthy adult volunteers

Botanical extract from vietnamese plant tested for safety in first human trial

What the study statuses mean