Cadmium Exceeds the StandardPhase 1NCT06199349
Safety Study of GMDTC Injection in Participants With Excessive Cadmium
A Phase 1 study testing GMDTC for injection and Normal saline in people with Cadmium Exceeds the Standard, run by Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cadmium Exceeds the Standard
- What is being tested?
- GMDTC for injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 5 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
China1 site
Hunan Occupational Disease Prevention and Control Institute
Changsha, Hunan, 410000
About this study
Official title: Phase Ib Clinical Study on the Safety, Tolerability and Pharmacokinetic Characteristics of GMDTC for Injection After Repeated Administration in People With Excessive Cadmium Levels
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.
Read the detailed 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.
- Conditions
- Cadmium Exceeds the Standard
- Being tested
- GMDTC for injection, Normal saline
- Keywords
- cadmium, Cadmium Poisoning, Therapeutics, Drugs, Investigational, GMDTC
- Medical subject headings
- Cadmium Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMDTC for injectionDrug
Also called GMDTC Group
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.
Normal salineOther
Also called Normal saline group
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days
Secondary outcomes (9)
Pharmacokinetic parameters,Tmax
Peak time, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic parameters, Cmax
Peak concentrations, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic parameters, λz
The apparent terminal elimination rate constant, obtained by taking a half-log linear regression at the elimination phase concentration point, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic parameters, t1/2
the apparent terminal elimination half-life, calculated according to the following equation:t1/2= Ln(2)/ λz,reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters, blood cadmium
blood cadmium concentration before and after drug administration
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters, urine cadmium
urine cadmium level before and after drug administration (μmol/mol creatinine)
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters, 24-hour urine cadmium
24-hour urine cadmium excretion before and after drug administration
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters,serum electrolyte and trace element
serum electrolyte and trace element concentrations before and after drug administration
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters, other blood heavy metals
whole blood heavy metal levels before and after drug administration
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start8 Jan 2024
- Primary completion21 Oct 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cadmium Exceeds the StandardStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Lai, Principal investigator, Hunan Occupational Disease Prevention and Control InstituteFang Pei, PhD-c, Principal investigator, Hunan Occupational Disease Prevention and Control Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199349
- Sponsor's protocol ID
- JianerShengPharmaTCIb
- Status last verified
- Feb 2025
- First submitted
- 29 Dec 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27282297Li 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.
Guidelines for the management of Phase I clinical trials of drugs (trial implementation)
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Clinical Study on the Safety, Tolerability and Pharmacokinetic Characteristics of GMDTC for Injection After Repeated Administration in People With Excessive Cadmium Levels
- ClinicalTrials.gov ID
- NCT06199349
- Acronym / sponsor ID
- JianerShengPharmaTCIb
- Conditions
- Cadmium Exceeds the Standard
- Keywords
- cadmium, Cadmium Poisoning, Therapeutics, Drugs, Investigational, GMDTC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMDTC group | Experimental | Drug: GMDTC for injectionThe subjects assigned to the GMDTC group will be administered once every morning after eating a standard breakfast on D1-D3 and D8-D10. |
| Normal saline group | Placebo comparator | Other: Normal salineThe subjects assigned to the placebo group will be administered once every morning after eating a standard breakfast on D1-D3 and D8-D10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMDTC for injectionAlso: GMDTC GroupGMDTC 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. | Drug | GMDTC group |
| Normal salineAlso: Normal saline group0.9% 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 | Other | Normal saline group |
Primary outcome
Adverse events
Time frame: Up to 30 days
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.
9 secondary outcomes
Pharmacokinetic parameters,Tmax
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic parameters, Cmax
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic parameters, λz
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic parameters, t1/2
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters, blood cadmium
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters, urine cadmium
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters, 24-hour urine cadmium
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters,serum electrolyte and trace element
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacodynamic parameters, other blood heavy metals
Time frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Background: PubMed 27282297Tang 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.
- BackgroundLi 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.
- BackgroundGuidelines for the management of Phase I clinical trials of drugs (trial implementation)
- Individual participant dataSharing planned: No
Related trials for Cadmium Exceeds the Standard
RecruitingPhase 2
The Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels
Cadmium Exceeds the Standard
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Lai principal investigator
Hunan Occupational Disease Prevention and Control Institute
Fang Pei, PhD-c principal investigator
Hunan Occupational Disease Prevention and Control Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GMDTC for injection and Normal saline in people with Cadmium Exceeds the Standard, run by Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199349, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.