NCT05908383

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

May 30, 2023

Last Update Submit

December 29, 2023

Conditions

Cadmium Exposure

Keywords

cadmiumCadmium PoisoningTherapeuticsDrugs, Investigational

Outcome Measures

Primary Outcomes (2)

  • 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.

    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℃

    up to 1 weeks

Secondary Outcomes (9)

  • Pharmacokinetic parameters,Tmax

    Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

  • Pharmacokinetic parameters, Cmax

    Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

  • Pharmacokinetic parameters, λz

    Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

  • Pharmacokinetic parameters, t1/2

    Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

  • Pharmacodynamic parameters, blood cadmium

    Evaluated at baseline, during drug infusion, and within 24 hours after drug administration

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Other: Normal saline

Interventions

GMDTC for injectionDRUG

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.

Also known as: GMDTC Group
GMDTC for injection
Normal salineOTHER

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.

Also known as: Normal saline Group
Normal saline group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Occupational Disease Prevention and Control Institute

Changsha, Hunan, 410000, China

Location

Related Publications (4)

  • 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.

    PMID: 27282297BACKGROUND

  • 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.

    BACKGROUND

  • Guidelines for the management of Phase I clinical trials of drugs (trial implementation).

    BACKGROUND

  • Guidelines for the validation of quantitative analysis methods for biological samples in the 2020 edition of the Chinese Pharmacopoeia.

    BACKGROUND

MeSH Terms

Conditions

Cadmium Poisoning

Interventions

InjectionsSaline Solution

Condition Hierarchy (Ancestors)

Heavy Metal PoisoningPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Fang Pei, PhD-c

    Hunan Occupational Disease Prevention and Control Institute

    PRINCIPAL INVESTIGATOR

  • Xiaobin Deng

    Hunan Occupational Disease Prevention and Control Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This clinical study is a double-blind study, in which participants such as clinical researchers, project managers, and project monitors are unaware of the random coding and drug administration groups of the subjects. Non-blind monitoring during the clinical study will be conducted by non-blind monitors. In addition, drug preparation will be carried out by non-blind researchers independent of this study. Analysis and testing personnel will also adopt blind analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 18, 2023

Study Start

January 30, 2023

Primary Completion

June 30, 2023

Study Completion

July 30, 2023

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)