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NCT04135898
A Study Comparing SIBP-04 and Bevacizumab in Healthy Male Subjects
Phase 1 trial testing SIBP-04 in Healthy Male in 88 participants. Completed in 16 March 2020.
16 March 2020
Quick facts
| Lead sponsor | Shanghai Institute Of Biological Products |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 88 |
| Start date | 23 October 2019 |
| Primary completion | 16 March 2020 |
| Estimated completion | 16 March 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- SIBP-04 — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
Conditions studied
- Healthy Male — all drugs for Healthy Male →
Sponsor
Shanghai Institute Of Biological Products
Who can join
Adults 18 to 45, male only, with Healthy Male. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomised, double-blind, positive drug parallel controlled clinical trial in China. In the trial, it is planned to enroll 88 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and safety of bevacizumab biosimilar SIBP04 compared with bevacizumab (Avastin®) as first-line treatment for locally advanced or metastatic non-squamous non-small-cell lung cancer: A randomized, double-blind, phase 3 trial.
Shi Y, Bi M, Li Q, Wang G, et al · · 2025 · cited 2× · PMID 40697509 · DOI 10.1016/j.cpt.2025.01.001
Verify or expand the search:
- PubMed search for NCT04135898
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Shanghai Institute Of Biological Products trials
Trials by the same sponsor.
- NCT07363837 — Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants · Phase 1, PHASE2 · not yet recruiting
- NCT07327398 — Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 2 · not yet recruiting
- NCT07253675 — Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo · Phase 2 · not yet recruiting
- NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
- NCT07205198 — A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects. · Phase 1 · recruiting
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 NCT04135898 (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 Shanghai Institute Of Biological Products
- Last refreshed: 29 December 2023
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/NCT04135898.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing