Cadmium ExposurePhase 1NCT05908383
Safety Study of GMDTC Injection in Healthy Participants
A Phase 1 study testing GMDTC for injection and Normal saline in people with Cadmium Exposure, 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 injectable GMDTC in healthy subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cadmium Exposure
- 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
- 76 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2023to 30 Jul 2023
- 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
- Healthy volunteers accepted
- 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;
- Subjects must voluntarily sign a written informed consent form.
Who cannot join
- past or current clinical significant diseases that affect the circulatory, endocrine, nervous, digestive, respiratory, renal, hematological, immunological, psychiatric, and metabolic systems or any other disease or symptom that may interfere with the study results;
- eGFR<90 mL/min/l.73 m2 during screening (eGFR calculated using the Cockcroft-Gault formula: eGFR (mL/min/1.73 m2) =*(140-age)weight (kg)/[0.818Cr (umol/L)]*0.85 (female));
- urine creatinine (Cr) > 5 umol/mol for two consecutive days during screening (with a creatinine concentration of≥0.3 g/L and ≤3 ug/L);
- a history of allergy to drugs, food, or other substances, especially to the components of the study drug;
- undergone or planned surgery that affects drug metabolism and safety assessment within 4 weeks before screening;
- use of any medication or health supplements (including Chinese herbal medicine) within 14 days before screening;
Show all 17Show fewer
- participated in any clinical trial and used any investigational drug within three months before screening;
- blood donation or significant blood loss (≥200 mL, excludingmenstrual bleeding in women) within 3 months before screening, blood transfusion, or use of blood products;
- 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;
- daily consumption of excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups, 1 cup - 250 mL);
- 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;
- clinically significant abnormalities in vital signs, physical examination, electrocardiogram, electroencephalogram, cardiac ultrasound, abdominal ultrasound, chest CT, ophthalmic examination, or laboratory tests (as judged by the clinical research physician)
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 I Clinical Study on the Safety, Tolerability and Pharmacokinetic Characteristics of a Single Dose of GMDTC Administered to Healthy Subjects for Injection
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 injectable GMDTC in healthy subjects
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of a single dose of injectable GMDTC in healthy subjects and to determine the maximum tolerated dose (MTD). The secondary objective is to evaluate the pharmacokinetic characteristics of injectable GMDTC after a single dose in healthy subjects and its impact on cadmium levels in the body.The modified Fibonacci method (also known as the Fibonacci dose escalation method) was used for dose escalation, with six predetermined dose groups.
- Conditions
- Cadmium Exposure
- Being tested
- GMDTC for injection, Normal saline
- Keywords
- cadmium, Cadmium Poisoning, Therapeutics, Drugs, Investigational
- 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, 250mg,500mg,850mg,1200mg,1600mg,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 for injection | Experimental | The subjects assigned to the treatment group will receive once medication at 8:00 am on the second day after admission. Receives: Drug: GMDTC for injection |
| Normal saline group | Placebo comparator | The subjects assigned to the placebo group will receive once medication at 8:00 am on the second day after admission. 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
DLT
DLT is defined as the occurrence of any of the following adverse events defined by NCI CTCAE V5.0 after drug administration: 1) grade 3 (severe) toxicity related to the investigational drug, such as events resulting in hospitalization or leading to serious or permanent disability or defect; 2) grade 4 (life-threatening) toxicity or any toxicity deemed by the investigator to be significantly severe; 3) grade 3 neutropenia accompanied by infection or fever of ≥38.5℃
Measured: up to 1 weeks
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 posted18 Jun 2023
- Study start30 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cadmium ExposureStudies 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fang Pei, PhD-c, Principal investigator, Hunan Occupational Disease Prevention and Control InstituteXiaobin Deng, Principal investigator, Hunan Occupational Disease Prevention and Control Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908383
- Sponsor's protocol ID
- JianerShengPharmaTC
- Status last verified
- Dec 2023
- First submitted
- 30 May 2023
- Last updated
- 2 Jan 2024
- 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).
Guidelines for the validation of quantitative analysis methods for biological samples in the 2020 edition of the Chinese Pharmacopoeia.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetic Characteristics of a Single Dose of GMDTC Administered to Healthy Subjects for Injection
- ClinicalTrials.gov ID
- NCT05908383
- Acronym / sponsor ID
- JianerShengPharmaTC
- Conditions
- Cadmium Exposure
- Keywords
- cadmium, Cadmium Poisoning, Therapeutics, Drugs, Investigational
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 18 Jun 2023 (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 injectable GMDTC in healthy subjects
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of a single dose of injectable GMDTC in healthy subjects and to determine the maximum tolerated dose (MTD). The secondary objective is to evaluate the pharmacokinetic characteristics of injectable GMDTC after a single dose in healthy subjects and its impact on cadmium levels in the body.The modified Fibonacci method (also known as the Fibonacci dose escalation method) was used for dose escalation, with six predetermined dose groups.
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 for injection | Experimental | Drug: GMDTC for injectionThe subjects assigned to the treatment group will receive once medication at 8:00 am on the second day after admission. |
| Normal saline group | Placebo comparator | Other: Normal salineThe subjects assigned to the placebo group will receive once medication at 8:00 am on the second day after admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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;
- Subjects must voluntarily sign a written informed consent form.
Key exclusion criteria (17 listed)
- past or current clinical significant diseases that affect the circulatory, endocrine, nervous, digestive, respiratory, renal, hematological, immunological, psychiatric, and metabolic systems or any other disease or symptom that may interfere with the study results;
- eGFR<90 mL/min/l.73 m2 during screening (eGFR calculated using the Cockcroft-Gault formula: eGFR (mL/min/1.73 m2) =*(140-age)weight (kg)/[0.818Cr (umol/L)]*0.85 (female));
- urine creatinine (Cr) > 5 umol/mol for two consecutive days during screening (with a creatinine concentration of≥0.3 g/L and ≤3 ug/L);
- a history of allergy to drugs, food, or other substances, especially to the components of the study drug;
- undergone or planned surgery that affects drug metabolism and safety assessment within 4 weeks before screening;
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, 250mg,500mg,850mg,1200mg,1600mg,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 for injection |
| 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.
DLT
Time frame: up to 1 weeks
DLT is defined as the occurrence of any of the following adverse events defined by NCI CTCAE V5.0 after drug administration: 1) grade 3 (severe) toxicity related to the investigational drug, such as events resulting in hospitalization or leading to serious or permanent disability or defect; 2) grade 4 (life-threatening) toxicity or any toxicity deemed by the investigator to be significantly severe; 3) grade 3 neutropenia accompanied by infection or fever of ≥38.5℃
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 2 Jan 2024.
- 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).
- BackgroundGuidelines for the validation of quantitative analysis methods for biological samples in the 2020 edition of the Chinese Pharmacopoeia.
- Individual participant dataSharing planned: No
Related trials for Cadmium Exposure
RecruitingObservational study
Cadmium Exposure During Pregnancy and Fetal Growth
Cadmium, Placenta
Enrolling by invitationObservational study
Assessing Toxic Metal Exposure From Vegetarian/Vegan, Omnivorous, and Low-carb Diets in Israel.
Environmental Exposure; Dietary Patterns; Nutritional Epidemiology; Human Biomonitoring
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.
Fang Pei, PhD-c principal investigator
Hunan Occupational Disease Prevention and Control Institute
Xiaobin Deng 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 Exposure, 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 3 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 2 Jan 2024. 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). The study lists 2 primary outcomes in all. 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 NCT05908383, which also lists 4 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 2 Jan 2024.