Phase I Clinical Study on the Safety, Tolerability and Pharmacokinetic Characteristics of a Single Dose of GMDTC Administered to Healthy Subjects for Injection
Overview
- Phase
- Phase 1
- Intervention
- GMDTC for injection
- Conditions
- Cadmium Exposure
- Sponsor
- Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
GMDTC for injection
The subjects assigned to the treatment group will receive once medication at 8:00 am on the second day after admission.
Intervention: GMDTC for injection
Normal saline group
The subjects assigned to the placebo group will receive once medication at 8:00 am on the second day after admission.
Intervention: Normal saline
Outcomes
Primary Outcomes
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℃
Secondary Outcomes
- Pharmacokinetic parameters,Tmax(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)
- Pharmacodynamic parameters, urine cadmium(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)
- Pharmacodynamic parameters,serum electrolyte and trace element(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, 24-hour urine cadmium(Evaluated at baseline, during drug infusion, and within 24 hours after drug administration)
- Pharmacodynamic parameters, other blood heavy metals(Evaluated at baseline, during drug infusion, and within 24 hours after drug administration)