Cadmium Exceeds the StandardPhase 2NCT07057414

The Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels

A Phase 2 study testing GMDTC for injection and 0.9% Sodium Chloride Injection(0.9% NaCl) in people with Cadmium Exceeds the Standard, run by Guangdong Jianersheng Pharmaceutical Technology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cadmium Exceeds the Standard
What is being tested?: GMDTC for injection and 0.9% Sodium Chloride Injection(0.9% NaCl)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteChina
Study dates: 7 Jul 2025to 30 Dec 2025
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Study participants must meet all of the following criteria to be enrolled in this trial:
Voluntarily sign the informed consent form, aged between 18 and 70 years (inclusive), regardless of gender;
Single morning urine cadmium >5 μg/g creatinine (with creatinine concentration ≥0.3 g/L and ≤3 g/L);
eGFR ≥30 mL/min/1.73 m² (calculated using the CKD-EPI formula).

Who cannot join

Participants who meet any of the following criteria will be excluded from this study:
Currently suffering from any clinically significant disease that, in the investigator's judgment, poses a safety risk for participation in this clinical trial;
Patients with a history of kidney disease requiring hemodialysis;
Patients with a history of severe infusion-related allergic reactions, known allergies to three or more substances, or known hypersensitivity to any component of this product (e.g., disodium edetate, mannitol);
Previous diagnosis of diabetes with poorly controlled blood glucose;
History of conditions predisposing to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism);
High-risk uncontrolled arrhythmia within the past 6 months, including:
1) Resting atrial tachycardia with heart rate >100 bpm, 2) Significant ventricular arrhythmia (e.g., ventricular tachycardia), 3) High-grade atrioventricular block (e.g., Mobitz type II second-degree or third-degree AV block), 4) NYHA Class IV heart failure, 5) Left ventricular ejection fraction (LVEF) <50%; 7.Prolonged QT/QTc interval at screening/baseline (QTc: >450 ms in males, >470 ms in females) or known family history of long QT syndrome; 8. Use of any medication or supplement (e.g., SGLT2 inhibitors like dapagliflozin, canagliflozin, empagliflozin, etc.; GLUT2 inhibitors like cytochalasin B, phloretin, etc.) within 14 days prior to screening that may interact with the investigational drug; 9. Participation in any other clinical trial involving investigational drugs or medical devices within 3 months prior to screening; 10. Major surgery within 4 weeks before screening or planned surgery during the trial that may affect drug metabolism or safety assessment; 11. Blood donation or significant blood loss (≥200 mL, excluding menstrual bleeding), transfusion, or use of blood products within 1 month prior to screening; 12. Intolerance to venipuncture and/or history of syncope due to blood or needle exposure; 13. Pregnant or lactating women, or participants unwilling to use effective non-pharmacological contraception during the trial; 14. Inability to use contraception for 6 months after trial completion; 15.Inability to comply with dietary restrictions or nutritional guidelines; 16.Alcohol abuse or regular alcohol consumption (>14 units/week; 1 unit ≈ 200 mL beer [5%], 25 mL spirits [40%], or 85 mL wine [12%]) within 6 months before screening, or unwillingness to abstain from alcohol during the trial; 17. Participants with unstable psychiatric disorders, in the investigator's opinion, who cannot cooperate with the study; 18. Any other condition deemed by the investigator to compromise study compliance or safety.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaojiang Tang, PhD contact

13719282259

tangxiaojiang@jesgmdtc.com

Wei Hu, PhD contact

15011814225

huwei@jesgmdtc.com

China1 site, 1 recruiting

Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment
Guangzhou, Guangdong, 510300
Yanyan Wang, M.Med., 15876522725, ilvyan@126.com
Ming Huang, PhD, 18922195007, echo.echo@126.com
Recruiting

Other trials in China

About this study

Official title: Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study to Evaluate the Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels

This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.

Read the detailed description

The primary objective of this study is to evaluate the pharmacodynamic characteristics of GMDTC for Injection in subjects with elevated cadmium levels after administration, while the secondary objectives are to assess the safety, tolerability and pharmacokinetic profile of GMDTC for Injection following multiple-dose administration in the same population; based on the results from Phase I single- and multiple-dose studies, the initial dose group in this trial is set at 2000 mg with a concentration of 4 mg/mL, where the first 4 participants (including 3 in the treatment group and 1 in the placebo group) will be enrolled first, and subsequent participants in the same dose group can only continue enrollment after investigators complete the 72-hour post-dose safety and tolerability assessments and confirm favorable results, with the SMC meeting to determine subsequent study plans including but not limited to dose escalation, concentration adjustment or increased treatment duration after completion of observation for each dose group.

Conditions: Cadmium Exceeds the Standard
Being tested: GMDTC for injection, 0.9% Sodium Chloride Injection(0.9% NaCl)
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
GMDTC for Injection with a specification of 0.5g/vial, and administered by intravenous infusion. According to the drug preparation SOP , Using 0.9% physiological saline to achieve the required concentration for each dose group (e.g., The initial dose group: 2 g reconstituted in 500 mL, with each 1 g reconstituted in 250 mL, resulting in a 4 mg/mL concentration.). All infusion-related reactions must be documented. Drug preparation must be performed by an non-blind investigator independent of the study to maintain blinding integrity for other study personnel.
0.9% Sodium Chloride Injection(0.9% NaCl)Other
0.9% Sodium Chloride Injection with a specification of 250mL/bag, and administered by intravenous infusion. The infusion should be strictly adhering to the assigned dosage. All infusion-related reactions must be documented. Drug preparation must be performed by an non-blind investigator independent of the study to maintain blinding integrity for other study personnel.

Study groups in NCT07057414
Study group	Role	What they receive
GMDTC Group	Experimental	Participants randomized to the GMDTC Group will receive daily administrations (GMDTC for Injection ) after breakfast from Day 1 to Day 5 and Day 8 to Day 12. Receives: Drug: GMDTC for injection
Placebo Group	Placebo comparator	Participants randomized to the Placebo Group will receive daily administrations (normal saline for Injection ) after breakfast from Day 1 to Day 5 and Day 8 to Day 12. Receives: Other: 0.9% Sodium Chloride Injection(0.9% NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacodynamic Parameters , 24-hour urinary cadmium
24-hour urinary cadmium excretion before and after drug administration(μg/L)
Measured: Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)

Secondary outcomes (18)

Adverse Events (AEs)
Clinical safety assessments during the trial will include: 1) all spontaneously reported and directly observed adverse events (AEs) and serious adverse events (SAEs); 2) any clinically significant changes in vital signs (as determined by the investigator); 3) clinically significant abnormalities (as determined by the investigator) observed during physical examinations, laboratory tests, electrocardiograms (ECG), cardiac ultrasound, abdominal ultrasound, thyroid ultrasound, chest CT scans, ophthalmologic examinations, auditory tests, and olfactory tests, with AE severity graded according to CTCAE v5.0 standards.
Measured: Within 30 days after the last dose administration
Pharmacodynamic Parameters , Urinary Cadmium and Lead Levels
urinary Cadmium and Lead Levels before and after drug administration (μg/g Creatinine)
Measured: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters , 24-Hour Urinary Lead and Copper
24-Hour Urinary Lead and Copper Excretion before and after drug administration(μg/L)
Measured: Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)
Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Pb, As, Hg, Cr, Mn)
Blood Heavy Metal/Metalloid Levels (Pb, As, Hg, Cr, Mn) before and after drug administration(μg/L)
Measured: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)
Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Cu, Zn)
Blood Heavy Metal/Metalloid Levels (Cu, Zn) before and after drug administration(mg/L)
Measured: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)
Pharmacodynamic Parameters , Renal Function Biomarker Levels(Creatinine-corrected urinary β2-MG, Creatinine-corrected urinary URBP)
Renal Function Biomarker Levels (Creatinine-corrected urinary β2-microglobulin, Creatinine-corrected URBP ) before and after drug administration (μg/g Creatinine)
Measured: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters , Renal Function Biomarker Levels(β2-MG, URBP)
Renal Function Biomarker Levels (Urinary β2-microglobulin (β2MG), Urinary retinol-binding protein (URBP)) before and after drug administration(μg/L)
Measured: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters , Renal Function Biomarker Levels(α1-MG)
Renal Function Biomarker Levels (Urinary α1-microglobulin) before and after drug administration(mg/L)
Measured: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters , Renal Function Biomarker Levels(NAG)
Renal Function Biomarker Levels (Urinary N-acetyl-β-D-glucosaminidase (NAG) ) before and after drug administration(U/L)
Measured: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(PTH)
Bone Metabolism Biomarker Levels(Parathyroid hormone (PTH)) before and after drug administration(pg/mL)
Measured: Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13)
Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(25(OH)D, P1NP, CTX)
Bone Metabolism Biomarker Levels(25-Hydroxyvitamin D, Serum procollagen type I N-terminal propeptide (P1NP), Serum C-terminal telopeptide of type I collagen (CTX)) before and after drug administration(ng/mL)
Measured: Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13)
Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(ALP)
Bone Metabolism Biomarker Levels(Serum alkaline phosphatase (ALP)) before and after drug administration(U/L)
Measured: Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13)
Pharmacodynamic Parameters , urinary cadmium Levels
Change in Urinary Cadmium Levels before and after drug administration (μg/g Creatinine)
Measured: Evaluated from Baseline (Pre-dose Day1) to First Void Post-dose (Day1-Day5 & Day8-Day12)
Pharmacodynamic Parameters , Blood Cadmium Concentration
Blood Cadmium (Cd) Concentration before and after drug administration(μg/L)
Measured: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)
Pharmacokinetic Parameters , Tmax
Time to reach peak concentration (observed value)
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic Parameters , Cmax
Peak concentration (observed value)
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic Parameters , λz
Apparent terminal elimination rate constant, derived from semi-log linear regression of elimination phase concentration points.
Measured: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
Pharmacokinetic Parameters , t1/2
Apparent terminal elimination half-life, calculated using the following equation: t1/2 = Ln(2) / λz
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.

7 Jul 202530 Dec 2025

First posted9 Jul 2025
Study start7 Jul 2025
Primary completion29 Oct 2025 (estimated)
Study completion30 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study anticipates 11 subjects per dose group (including 3 placebo controls), with the total sample size to be determined based on actual study progress.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 11 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07057414
Sponsor's protocol ID: GuangdongPharm IIa
Status last verified: Aug 2025
First submitted: 26 Jun 2025
Last updated: 2 Sep 2025
Results posted: No
Data monitoring committee: No
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 27282297

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study to Evaluate the Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels
ClinicalTrials.gov ID: NCT07057414
Acronym / sponsor ID: GuangdongPharm IIa
Conditions: Cadmium Exceeds the Standard
Keywords: Cadmium, Cadmium Poisoning, Therapeutics, Drugs, Investigational, GMDTC
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 11 participants (estimated)
Lead sponsor: Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.University, hospital or other
Collaborators: Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment
Study start: 7 Jul 2025 (actual)
Primary completion: 29 Oct 2025 (estimated)
Study completion: 30 Dec 2025 (estimated)
First posted: 9 Jul 2025 (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 is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This study anticipates 11 subjects per dose group (including 3 placebo controls), with the total sample size to be determined based on actual study progress.

Arm	Type	Receives
GMDTC Group	Experimental	Drug: GMDTC for injectionParticipants randomized to the GMDTC Group will receive daily administrations (GMDTC for Injection ) after breakfast from Day 1 to Day 5 and Day 8 to Day 12.
Placebo Group	Placebo comparator	Other: 0.9% Sodium Chloride Injection(0.9% NaCl)Participants randomized to the Placebo Group will receive daily administrations (normal saline for Injection ) after breakfast from Day 1 to Day 5 and Day 8 to Day 12.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Voluntarily sign the informed consent form, aged between 18 and 70 years (inclusive), regardless of gender;
Single morning urine cadmium >5 μg/g creatinine (with creatinine concentration ≥0.3 g/L and ≤3 g/L);
eGFR ≥30 mL/min/1.73 m² (calculated using the CKD-EPI formula).

Key exclusion criteria (8 listed)

Currently suffering from any clinically significant disease that, in the investigator's judgment, poses a safety risk for participation in this clinical trial;
Patients with a history of kidney disease requiring hemodialysis;
Patients with a history of severe infusion-related allergic reactions, known allergies to three or more substances, or known hypersensitivity to any component of this product (e.g., disodium edetate, mannitol);
Previous diagnosis of diabetes with poorly controlled blood glucose;
History of conditions predisposing to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism);

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 injectionGMDTC for Injection with a specification of 0.5g/vial, and administered by intravenous infusion. According to the drug preparation SOP , Using 0.9% physiological saline to achieve the required concentration for each dose group (e.g., The initial dose group: 2 g reconstituted in 500 mL, with each 1 g reconstituted in 250 mL, resulting in a 4 mg/mL concentration.). All infusion-related reactions must be documented. Drug preparation must be performed by an non-blind investigator independent of the study to maintain blinding integrity for other study personnel.	Drug	GMDTC Group
0.9% Sodium Chloride Injection(0.9% NaCl)0.9% Sodium Chloride Injection with a specification of 250mL/bag, and administered by intravenous infusion. The infusion should be strictly adhering to the assigned dosage. All infusion-related reactions must be documented. Drug preparation must be performed by an non-blind investigator independent of the study to maintain blinding integrity for other study personnel.	Other	Placebo Group

Primary outcome

Pharmacodynamic Parameters , 24-hour urinary cadmium
Time frame: Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)
24-hour urinary cadmium excretion before and after drug administration(μg/L)

18 secondary outcomes

Adverse Events (AEs)
Time frame: Within 30 days after the last dose administration
Pharmacodynamic Parameters , Urinary Cadmium and Lead Levels
Time frame: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters , 24-Hour Urinary Lead and Copper
Time frame: Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)
Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Pb, As, Hg, Cr, Mn)
Time frame: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)
Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Cu, Zn)
Time frame: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)
Pharmacodynamic Parameters , Renal Function Biomarker Levels(Creatinine-corrected urinary β2-MG, Creatinine-corrected urinary URBP)
Time frame: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters , Renal Function Biomarker Levels(β2-MG, URBP)
Time frame: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters , Renal Function Biomarker Levels(α1-MG)
Time frame: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters , Renal Function Biomarker Levels(NAG)
Time frame: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)
Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(PTH)
Time frame: Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13)
Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(25(OH)D, P1NP, CTX)
Time frame: Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13)
Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(ALP)
Time frame: Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13)
Pharmacodynamic Parameters , urinary cadmium Levels
Time frame: Evaluated from Baseline (Pre-dose Day1) to First Void Post-dose (Day1-Day5 & Day8-Day12)
Pharmacodynamic Parameters , Blood Cadmium Concentration
Time frame: Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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.
Individual participant dataSharing planned: No

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.

Xiaojiang Tang, PhD contact

13719282259

tangxiaojiang@jesgmdtc.com

Wei Hu, PhD contact

15011814225

huwei@jesgmdtc.com

Yanyan Wang, M.Med. principal investigator

Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment

Ming Huang, PhD principal investigator

Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: looking for participants now, as of the sponsor's last update on 2 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaojiang Tang, PhD (13719282259, tangxiaojiang@jesgmdtc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacodynamic Parameters , 24-hour urinary cadmium (time frame: Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)). 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 NCT07057414, which also lists 1 linked publication.

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 2 Sep 2025.