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NCT02912247
Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
Phase 1 trial testing human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection in Healthy in 183 participants. Completed in 22 September 2017.
22 September 2017
Quick facts
| Lead sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 183 |
| Start date | 27 October 2016 |
| Primary completion | 22 September 2017 |
| Estimated completion | 22 September 2017 |
Drugs / interventions tested
- human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection — full drug profile →
- adalimumab (ADALIMUMAB) — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. — 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
This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection and Adalimumab when used as a single subcutaneous injection in healthy volunteers.
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 NCT02912247
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Innovent Biologics (Suzhou) Co. Ltd. trials
Trials by the same sponsor.
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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 NCT02912247 (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: 7 March 2019
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/NCT02912247.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing