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NCT05005455
Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects
Phase 1 trial testing bevacizumab with new manufacturing process. in Healthy Male Subjects in 100 participants. Completed in 28 January 2022.
28 January 2022
Quick facts
| Lead sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 100 |
| Start date | 30 July 2021 |
| Primary completion | 28 January 2022 |
| Estimated completion | 28 January 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- bevacizumab with new manufacturing process. — full drug profile →
- bevacizumab with old manufacturing process. — full drug profile →
Conditions studied
- Healthy Male Subjects — all drugs for Healthy Male Subjects →
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. — full company profile →
Who can join
Adults 18 to 50, male only, with Healthy Male Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05005455
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy Male Subjects
Currently open trials in the same condition.
- NCT07340476 — A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects · Phase 1 · active not recruiting
Other Innovent Biologics (Suzhou) Co. Ltd. trials
Trials by the same sponsor.
- NCT07502534 — A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers · Phase 1 · not yet recruiting
- NCT07469800 — Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity · Phase 3 · not yet recruiting
- NCT07473960 — IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia · Phase 3 · recruiting
- NCT07483567 — IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastri · Phase 2 · not yet recruiting
- NCT07483554 — IBI343 in Combination Therapy for Advanced Malignant Solid Tumors · Phase 2 · not yet 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 NCT05005455 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Innovent Biologics (Suzhou) Co. Ltd.
- Last refreshed: 10 June 2022
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/NCT05005455.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing