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Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium

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ClinicalTrials.gov Identifier: NCT03804749
Recruitment Status : Unknown
Verified January 2019 by shentu jianzhong, First Affiliated Hospital of Zhejiang University.
Recruitment status was:  Recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Guangdong Kangda Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
shentu jianzhong, First Affiliated Hospital of Zhejiang University

Tracking Information
First Submitted Date  ICMJE December 28, 2018
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE December 19, 2018
Estimated Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
  • Number of subjects with adverse events [ Time Frame: [ Day 1 to Day 140 ] ]
    Adverse events
  • the area under the plasma concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUC0-t) of suramin sodium [ Time Frame: [ Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters
  • the AUC from time zero to infinity (AUC0-inf) of suramin sodium [ Time Frame: [ Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters
  • maximum plasma concentration (Cmax ) of suramin sodium [ Time Frame: [ Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters
  • half life (t1/2) of suramin sodium [ Time Frame: [Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters
  • clearance (CL) of suramin sodium [ Time Frame: [ Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters
  • apparent volume of distribution(Vd) of suramin sodium [ Time Frame: [ Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters
  • the amount of drug excreted into the urine from time zero to time 7 days(Ae0-t) of suramin sodium [ Time Frame: [ Day 1 to Day 7 after study drug administration ] ]
    Pharmacokinetics parameters
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium in Healthy Chinese Adults
Brief Summary This is a randomized, double-blind, placebo-controlled, single-dose with three incremental doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for injection in Chinese healthy adults.
Detailed Description

A total of 36 subjects are divided into three dosage groups: 10mg/kg, 15mg/kg and 20mg/kg, in which 20mg/kg is the conventional dosage per international pharmacopoeias for established indications of suramin sodium. Each dose group contains 12 subjects. By randomization, 10 of them receive suramin sodium while 2 of them receive placebo (0.9% sodium chloride injection). The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.

All subjects in each dose group will be un-blinded after blood/urine collection and safety evaluation on Day 28. After that, blood and urine samples on suramin-dosing subjects will continue to collect on Days 56、84、112 and 140.

Subjects receiving placebo will complete the study on Day 28 if no AE is observed, or follow up till the adverse event (AE) return to normal or stabilize if AE is detected.

Blood and urine samples will be tested by a validated LC/MS method for pharmacokinetic study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double blind, placebo control
Primary Purpose: Treatment
Condition  ICMJE Hand, Foot and Mouth Disease
Intervention  ICMJE
  • Drug: suramin sodium
    The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.。
  • Other: placebo
    Placebo is 0.9% sodium chloride injection.
    Other Name: 0.9% sodium chloride injection
Study Arms  ICMJE
  • Experimental: Group 1-1
    The dose of suramin sodium is 10 mg/kg
    Intervention: Drug: suramin sodium
  • Placebo Comparator: Group 1-2
    The placebo is 0.9% sodium chloride injection
    Intervention: Other: placebo
  • Experimental: Group 2-1
    The dose of suramin sodium is 15mg/kg
    Intervention: Drug: suramin sodium
  • Placebo Comparator: Group 2-2
    The placebo is 0.9% sodium chloride injection
    Intervention: Other: placebo
  • Experimental: Group 3-1
    The dose of suramin sodium is 20mg/kg
    Intervention: Drug: suramin sodium
  • Placebo Comparator: Group 3-2
    The placebo is 0.9% sodium chloride injection
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 11, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 19, 2020
Estimated Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy volunteers who fully understand the purpose, content, benefits and possible adverse reactions of the test and voluntarily sign written informed consent prior to the commencement of any test-related activities.
  2. Healthy males or females, aged 18 to 45 years (including 18 and 45 years).
  3. Male subjects weighed 50-75 kg (including 50 and 75 kg), female subjects weighed 45-75 kg (including 45 and 75 kg), body mass index (BMI) was 18.0-26.0 kg/m2 (including 18.0 and 26.0 kg/m2), where BMI = body weight (kg)/height2 (m2).
  4. Have the ability to communicate with investigator and abide by the management regulations of the hospital and the clinical research.

Exclusion Criteria:

  1. Fail in physical examination, vital signs measurement, standard 12-lead electrocardiogram, chest X-ray, laboratory examination [blood routine, urine routine, blood biochemistry, blood coagulation function, infectious diseases, blood pregnancy (only for women of childbearing age), as judged by the investigator to be of clinical significance.
  2. With gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immunity, mental or cardiovascular diseases.
  3. Has allergic constitution (allergic to two or more substances), or allergic history, or known allergic to suramin sodium.
  4. Cannot tolerate venipuncture and/or have a history of fainting blood or needle.
  5. Has massive blood loss (> 400 mL) or had donated blood/blood components within the first six months of screening, or who planned to donate blood/blood components during the study period.
  6. Had participated in clinical trials of drugs and took research drugs within three months before screening.
  7. Smoke more than five cigarettes a day (including nicotine substitutes) or the same amount of tobacco products in the first three months of screening.
  8. Has history of drug abuse within 5 years before screening, or those who had used drugs within 3 months before screening.
  9. Has a history of alcoholism or moderate alcoholism in the first two years of screening (moderate alcoholism is defined as drinking more than 3 units per day or 21 units per week; a bottle of 350 mL beer, 120 mL white wine, 150 mL wine or 30 mL spirits is one unit).
  10. Pregnant or lactating women, or subjects (or their partners) who have pregnancy plans during the trial and within three months after the end of the study, or who do not agree to use non-drug contraceptive measures during the trial.
  11. Positive urine drug screening in screening stage.
  12. Alcohol urine positive in screening stage.
  13. Nicotine positive in screening stage.
  14. With acute diseases in screening period.
  15. Had used any prescription, over-the-counter, vitamin products or Chinese herbal medicines within 14 days before enrollment.
  16. Female subjects of childbearing age who did not take non-drug contraceptive measures within 14 days before admission.
  17. Not suitable for participating into the trial as judged by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03804749
Other Study ID Numbers  ICMJE LC00-043
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party shentu jianzhong, First Affiliated Hospital of Zhejiang University
Study Sponsor  ICMJE First Affiliated Hospital of Zhejiang University
Collaborators  ICMJE Guangdong Kangda Pharmaceutical Co., Ltd
Investigators  ICMJE
Principal Investigator: First Affiliated Hospital Zhejiang University First Affiliated Hospital of Zhejiang University
PRS Account First Affiliated Hospital of Zhejiang University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP