drugset / Trial / NCT06199349
Safety Study of GMDTC Injection in Participants With Excessive Cadmium
RandomizedParallel-groupQuadruple-blindOther
Summary
This trial is a randomized, double-blind, single-center, single-dose escalating Phase I clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of GMDTC for injection after repeated administration in people with excessive cadmium levels.
Timeline
- Start
- 2024-01-08
- Primary completion
- 2024-10-21
- Completion
- 2024-12-05
Publications
- Background Tang X, Zhu J, Zhong Z, Luo M, Li G, Gong Z, Zhang C, Fei F, Ruan X, Zhou J, Liu G, Li G, Olson J, Ren X. Mobilization and removing of cadmium from kidney by GMDTC utilizing renal glucose reabsorption pathway. Toxicol Appl Pharmacol. 2016 Aug 15;305:143-152. doi: 10.1016/j.taap.2016.06.001. Epub 2016 Jun 6.
- Background Li Guangxian. Study on the efficacy of GMDTC in removing cadmium and its toxic side effects in chronic cadmium-poisoned mice and rats [D]. Guangdong Pharmaceutical University, 2015.
- Background Guidelines for the management of Phase I clinical trials of drugs (trial implementation)
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GMDTC | Unknown | 500 mg | Intravenous |
| Subject | GMDTC | Unknown | 1000 mg | Intravenous |
| Subject | GMDTC | Unknown | 2000 mg | Intravenous |
Indications
No indication recorded.