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NCT01481597
Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin in Healthy Volunteers
Phase 1 trial testing deuteporfin in Healthy in 32 participants. Completed in 1 April 2012.
1 April 2012
Quick facts
| Lead sponsor | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 1 November 2011 |
| Primary completion | 1 April 2012 |
| Estimated completion | 1 April 2012 |
| Sites | 1 location across China |
Drugs / interventions tested
- deuteporfin — full drug profile →
- deuteporfin — full drug profile →
- deuteporfin — full drug profile →
- deuteporfin — full drug profile →
- placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
number of participants with adverse events
Time frame: up to 19 days following injection
number of participants with adverse events as a measure of safety and tolerability of single dose of deuteporfin administered to healthy subjects
Sponsor's own description
Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following single-dose administration.
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 NCT01481597
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Fudan-Zhangjiang Bio-Pharmaceutical 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 NCT01481597 (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 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Last refreshed: 14 May 2012
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/NCT01481597.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing