- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05908383
Safety Study of GMDTC Injection in Healthy Participants
December 29, 2023 updated by: Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaojiang Tang, PhD
- Phone Number: 86+13719282259
- Email: river-t@126.com
Study Contact Backup
- Name: Wei Hu, PhD
- Phone Number: 86+15011814225
- Email: jeshuwei@163.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Hunan Occupational Disease Prevention and Control Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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;
- Subjects must voluntarily sign a written informed consent form.
Exclusion Criteria:
- 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;
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GMDTC for injection
The subjects assigned to the treatment group will receive once medication at 8:00 am on the second day after admission.
|
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.
Other Names:
|
Placebo Comparator: Normal saline group
The subjects assigned to the placebo group will receive once medication at 8:00 am on the second day after admission.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 30 days
|
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℃
|
up to 1 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameters,Tmax
Time Frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
|
Peak time, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
|
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
|
Peak concentrations, reflecting the absorption, distribution, metabolism and excretion characteristics of drugs in the body.
|
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
|
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.
|
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
|
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.
|
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
|
blood cadmium concentration before and after drug administration
|
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
|
urine cadmium level before and after drug administration (μmol/mol creatinine)
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Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
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Pharmacodynamic parameters, 24-hour urine cadmium
Time Frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
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24-hour urine cadmium excretion before and after drug administration
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Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
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Pharmacodynamic parameters,serum electrolyte and trace element
Time Frame: Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
|
serum electrolyte and trace element concentrations before and after drug administration
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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
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whole blood heavy metal levels before and after drug administration
|
Evaluated at baseline, during drug infusion, and within 24 hours after drug administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fang Pei, PhD-c, Hunan Occupational Disease Prevention and Control Institute
- Principal Investigator: Xiaobin Deng, Hunan Occupational Disease Prevention and Control Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2023
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
May 30, 2023
First Submitted That Met QC Criteria
June 9, 2023
First Posted (Actual)
June 18, 2023
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- JianerShengPharmaTC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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