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NCT03242239
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
Phase 1 trial testing ALT02 in Healthy in 105 participants. Completed in 30 September 2016.
4 August 2016
Quick facts
| Lead sponsor | Alteogen, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 105 |
| Start date | 9 February 2016 |
| Primary completion | 4 August 2016 |
| Estimated completion | 30 September 2016 |
Drugs / interventions tested
- ALT02 — full drug profile →
- EU-licensed Herceptin — full drug profile →
- US-licensed Herceptin — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Alteogen, Inc. — full company profile →
Who can join
Adults 18 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Monoclonal antibody biosimilars for cancer treatment.
Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115
Verify or expand the search:
- PubMed search for NCT03242239
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Alteogen, Inc. trials
Trials by the same sponsor.
- NCT05232175 — Clinical Study of ALT-BB4 to Determine Tolerance, Safety and Pharmacokinetics in Healthy Volunteer · Phase 1 · completed
- NCT04058535 — Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular AMD · Phase 1 · completed
- NCT03281824 — Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03242239 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Alteogen, Inc.
- Last refreshed: 21 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03242239.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing