Safety Study of GMDTC Injection in Participants With Excessive Cadmium (NCT06199349) | Clinical Trial Compass
CompletedPhase 1
Safety Study of GMDTC Injection in Participants With Excessive Cadmium
China30 participantsStarted 2024-01-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥18 years, both male and female are eligible;
* Male subjects must weigh at least 50.0 kg and female subjects must weigh at least 45.0 kg, with a body mass index (BMI) between 19 and 26 kg/m2, including the critical value;
* Urinary cadmium \>5 μmol/mol creatinine for 2 consecutive days during the screening period (creatinine content is ≥0.3 μg/L and ≤3 μg/L).
* Subjects must voluntarily sign a written informed consent form.
Exclusion Criteria:
* Those who are currently suffering from any clinically serious disease and the researcher determines that there are safety risks in participating in this clinical trial;
* Those with eGFR\<30 mL/min/1.73 m2 during screening (eGFR calculated using the Cockcroft-Gault formula: eGFR (mL/min/1.73 m2) =\*(140-age) \*weight (kg)/ \[0.818\*Cr (umol/L)\] \*0.85 (female));
* Those who have a history of allergies to 3 or more substances, or are allergic to any ingredients in this productï¼›
* Those who have undergone surgical procedures within 4 weeks before screening or plan to undergo surgical procedures that affect pharmacokinetics and safety determination during the study periodï¼›
* Those who have taken any drugs or health care products that may interact with the experimental drugs within 14 days before screening (such as SGLT2 inhibitors such as dapagliflozin, canagliflozin, empagliflozin, empagliflozin, canagliflozin, etc.) Gliflozin, Henggliflozin, Ipagliflozin, Rupagliflozin, Togliflozin, and the natural compou…