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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiaojiang Tang, PhD
  • Phone Number: 86+13719282259
  • Email: river-t@126.com

Study Contact Backup

Study Locations

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: GMDTC for injection
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:
  • GMDTC Group
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.
Other: Normal saline
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:
  • Normal saline Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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
24-hour urine cadmium excretion before and after drug administration
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
serum electrolyte and trace element concentrations before and after drug administration
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
whole blood heavy metal levels before and after drug administration
Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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