Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03804749
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Drug: suramin sodium Other: placebo Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blind, placebo control
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium in Healthy Chinese Adults
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : December 19, 2019
Estimated Study Completion Date : December 19, 2020

Arm Intervention/treatment
Experimental: Group 1-1
The dose of suramin sodium is 10 mg/kg
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.。

Placebo Comparator: Group 1-2
The placebo is 0.9% sodium chloride injection
Other: placebo
Placebo is 0.9% sodium chloride injection.
Other Name: 0.9% sodium chloride injection

Experimental: Group 2-1
The dose of suramin sodium is 15mg/kg
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.。

Placebo Comparator: Group 2-2
The placebo is 0.9% sodium chloride injection
Other: placebo
Placebo is 0.9% sodium chloride injection.
Other Name: 0.9% sodium chloride injection

Experimental: Group 3-1
The dose of suramin sodium is 20mg/kg
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.。

Placebo Comparator: Group 3-2
The placebo is 0.9% sodium chloride injection
Other: placebo
Placebo is 0.9% sodium chloride injection.
Other Name: 0.9% sodium chloride injection




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: [ Day 1 to Day 140 ] ]
    Adverse events

  2. 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

  3. 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

  4. maximum plasma concentration (Cmax ) of suramin sodium [ Time Frame: [ Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters

  5. half life (t1/2) of suramin sodium [ Time Frame: [Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters

  6. clearance (CL) of suramin sodium [ Time Frame: [ Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters

  7. apparent volume of distribution(Vd) of suramin sodium [ Time Frame: [ Day 1 to Day 140 after study drug administration ] ]
    Pharmacokinetics parameters

  8. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804749


Contacts
Layout table for location contacts
Contact: Jianzhong Shentu, Ph.D.(Pharm) 0571 87236560 stjz@zju.edu.cn

Locations
Layout table for location information
China, Zhejiang
First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Jianzhong Shentu, Ph.D.(Pharm)    0571 87236560    stjz@zju.edu.cn   
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Guangdong Kangda Pharmaceutical Co., Ltd
Investigators
Layout table for investigator information
Principal Investigator: First Affiliated Hospital Zhejiang University First Affiliated Hospital of Zhejiang University

Layout table for additonal information
Responsible Party: shentu jianzhong, Ph.D.(Pharm), First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03804749     History of Changes
Other Study ID Numbers: LC00-043
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by shentu jianzhong, First Affiliated Hospital of Zhejiang University:
suramin sodium

Additional relevant MeSH terms:
Layout table for MeSH terms
Mouth Diseases
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Suramin
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents