Safety Study of GMDTC Injection in Participants With Excessive Cadmium

NCT06199349 | Completed Phase 1 DMC

• 1 other identifier: JianerShengPharmaTCIb
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cadmium Exceeds the Standard

Keywords

cadmium; Cadmium Poisoning; Therapeutics; Drugs, Investigational; GMDTC

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, V5.0), which includes spontaneously reported adverse events as well as clinically significant changes in vital signs, physical examination, laboratory tests, electrocardiogram, and other examinations conducted during the trial.

  Up to 30 days

Secondary Outcomes (9)

• Pharmacokinetic parameters,Tmax

  Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

• Pharmacokinetic parameters, Cmax

  Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

• Pharmacokinetic parameters, λz

  Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

• Pharmacokinetic parameters, t1/2

  Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

• Pharmacodynamic parameters, blood cadmium

  Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

Study Arms (2)

GMDTC group

EXPERIMENTAL

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

Drug: GMDTC for injection

Normal saline group

PLACEBO COMPARATOR

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

Other: Normal saline

Interventions

GMDTC for injection DRUG

GMDTC for injection with a specification of 0.5g/vial, 500mg,1000mg,2000mg, and administered by intravenous infusion. Using 0.9% physiological saline (0.5g will be prepared with 250mL injection solution to achieve a concentration of 2mg/mL). Using an infusion pump at a rate of 4mL/min according to the dosage, and any infusion reactions will be recorded. The injection solution for both the experimental and placebo groups should be prepared by a non-blind investigator independent of the trial.

Also known as: GMDTC Group

GMDTC group

Normal saline OTHER

0.9% physiological saline for injection with a specification of 250ml/bag, and administered by intravenous infusion. Using an infusion pump at a rate of 4mL/min according to the dosage, and any infusion reactions will be recorded. The injection solution for both the experimental and placebo groups should be prepared by a non-blind investigator independent of the trial

Also known as: Normal saline group

Normal saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Hunan Occupational Disease Prevention and Control Institute

Changsha, Hunan, 410000, China

Location

Related Publications (3)

• 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.

  PMID: 27282297 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)

  BACKGROUND

MeSH Terms

Conditions

Cadmium Poisoning

Interventions

Injections; Saline Solution

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yan Lai

  Hunan Occupational Disease Prevention and Control Institute

  PRINCIPAL INVESTIGATOR

• Fang Pei, PhD-c

  Hunan Occupational Disease Prevention and Control Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This clinical study is a double-blind study, in which participants such as clinical researchers, project managers, and project monitors are unaware of the random coding and drug administration groups of the subjects. Non-blind monitoring during the clinical study will be conducted by non-blind monitors. In addition, drug preparation will be carried out by non-blind researchers independent of this study. Analysis and testing personnel will also adopt blind analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 10, 2024
• Study Start: January 8, 2024
• Primary Completion: October 21, 2024
• Study Completion: December 5, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)