Safety Study of GMDTC Injection in Participants With Excessive Cadmium

Jianersheng (Zhuhai) Pharmaceutical Technology

Status and phase: Completed; Phase 1

Conditions: Cadmium Exceeds the Standard

Treatments: Drug: GMDTC for injection; Other: Normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT06199349

JianerShengPharmaTCIb

Details and patient eligibility

About

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.

Full description

The primary objective of this study isto evaluate the safety and tolerability of injectable GMDTC for repeated administration in people with excessive cadmium. The secondary objective is to evaluate the pharmacokinetic and pharmacodynamic characteristics of GMDTC for injection in people with excessive cadmium levels after multiple administrations, and to explore the most effective dose. Based on the results of the single-dose study, three dose groups were designed, including a low-dose group, a medium-dose group, and a high-dose group.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 product；
• 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 period；
• 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 compound phlorizin, etc.; GLUT2 inhibitors such as cytochalasin B, phloretin, Huoxiang Zhengqi Powder, and Mignonette herbalin and isoorientin, etc.);
• Those who have used any clinical trial drugs or enrolled in any drug/medical device clinical trials within 3 months before screening;
• Those who donated blood or suffered massive blood loss (≥200 mL, excluding female menstrual blood loss), received blood transfusions or used blood products within 3 months before screening;
• inability to tolerate venipuncture and/or history of fainting or needle phobia;
• pregnant or lactating women, and subjects who cannot adopt effective non-drug contraceptive measures during the study period;
• unable to adopt contraceptive measures within 6 months after the end of the study;
• have special dietary requirements and cannot adhere to a uniform diet;
• Alcoholics or regular drinkers within 6 months before screening, that is, drinking more than 14 units of alcohol per week (1 unit ≈ 200 mL of beer with an alcohol content of 5% or 25 mL of spirits with an alcohol content of 40%- or 85-mL wine with an alcohol content of 12%) or who cannot stop using any alcohol-containing products during the trial;
• unable to stop using any tobacco products during the study period;
• alcoholics or frequent drinkers within 6 months before screening, i.e., drinking more than 14 units of alcohol per week (1 unit - 360.5 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or unable to stop using any alcohol-containing products during the study period;
• drug abusers or those who used soft drugs (such as marijuana) within 3 months before screening or used hard drugs (such as cocaine, benzoyl peroxide, etc.) within 1 year before screening;
• Laboratory tests must meet one or more of the following during screening: white blood cell count<3.0×109/L, neutrophil count <1.5×109/L, red blood cell count <3.0×1012/L, hemoglobin<100 g/L , platelet count <1 × LLN, total bilirubin > 2 × ULN, alanine aminotransferase > 2 × ULN, aspartate aminotransferase >2 × ULN；
• The subjects may not be able to complete the study due to other reasons or the researchers believe that they should not be included.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

GMDTC group

Experimental group

Description:

The subjects assigned to the GMDTC group will be administered once every morning after eating a standard breakfast on D1-D3 and D8-D10.

Treatment:

Drug: GMDTC for injection

Normal saline group

Placebo Comparator group

Description:

The subjects assigned to the placebo group will be administered once every morning after eating a standard breakfast on D1-D3 and D8-D10.

Treatment:

Other: Normal saline