Biosimilar cancer drug put to the test in healthy volunteers

NCT ID NCT03776240

Completed Knowledge-focused Sponsor: Prestige Biopharma Limited Source: ClinicalTrials.gov ↗

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This phase 1 trial tests whether a single dose of HD201, a biosimilar of the cancer drug trastuzumab (Herceptin), is processed by the body in the same way as the original European and US versions. Healthy male volunteers receive one intravenous infusion and have their blood levels measured over time. The goal is to show the drugs are equivalent, which could later support using HD201 as a more affordable alternative.

What this could mean

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

Active substance: HD201 (a biosimilar of trastuzumab)
What this could lead to: If HD201 is shown to be equivalent to Herceptin, it could offer a more affordable treatment option for certain cancers.
What could go wrong: This is an early-phase study in healthy volunteers, not patients. It only measures drug levels in the blood, not effectiveness against cancer. The biosimilar may still differ in real-world use.

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

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As listed by the trial registrant

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

HEALTHY VOLUNTEERS

Contacts and locations

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Locations

Q Pharm

Brisbane, Australia

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