Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium

NCT03804749 | Unknown Phase 1

• 1 other identifier: LC00-043
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand, Foot and Mouth Disease

Keywords

suramin sodium

Outcome Measures

Primary Outcomes (8)

• Number of subjects with adverse events

  Adverse events

  [ Day 1 to Day 140 ]

• 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

  Pharmacokinetics parameters

  [ Day 1 to Day 140 after study drug administration ]

• the AUC from time zero to infinity (AUC0-inf) of suramin sodium

  Pharmacokinetics parameters

  [ Day 1 to Day 140 after study drug administration ]

• maximum plasma concentration (Cmax ) of suramin sodium

  Pharmacokinetics parameters

  [ Day 1 to Day 140 after study drug administration ]

• half life （t1/2） of suramin sodium

  Pharmacokinetics parameters

  [Day 1 to Day 140 after study drug administration ]

• clearance （CL） of suramin sodium

  Pharmacokinetics parameters

  [ Day 1 to Day 140 after study drug administration ]

• apparent volume of distribution（Vd） of suramin sodium

  Pharmacokinetics parameters

  [ Day 1 to Day 140 after study drug administration ]

• the amount of drug excreted into the urine from time zero to time 7 days（Ae0-t） of suramin sodium

  Pharmacokinetics parameters

  [ Day 1 to Day 7 after study drug administration ]

Study Arms (6)

Group 1-1

EXPERIMENTAL

The dose of suramin sodium is 10 mg/kg

Drug: suramin sodium

Group 1-2

PLACEBO COMPARATOR

The placebo is 0.9% sodium chloride injection

Other: placebo

Group 2-1

EXPERIMENTAL

The dose of suramin sodium is 15mg/kg

Drug: suramin sodium

Group 2-2

PLACEBO COMPARATOR

The placebo is 0.9% sodium chloride injection

Other: placebo

Group 3-1

EXPERIMENTAL

The dose of suramin sodium is 20mg/kg

Drug: suramin sodium

Group 3-2

PLACEBO COMPARATOR

The placebo is 0.9% sodium chloride injection

Other: placebo

Interventions

suramin sodium DRUG

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.。

Group 1-1; Group 2-1; Group 3-1

placebo OTHER

Placebo is 0.9% sodium chloride injection.

Also known as: 0.9% sodium chloride injection

Group 1-2; Group 2-2; Group 3-2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Healthy males or females, aged 18 to 45 years (including 18 and 45 years).
• 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).
• Have the ability to communicate with investigator and abide by the management regulations of the hospital and the clinical research.

You may not qualify if:

• 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.
• With gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immunity, mental or cardiovascular diseases.
• Has allergic constitution (allergic to two or more substances), or allergic history, or known allergic to suramin sodium.
• Cannot tolerate venipuncture and/or have a history of fainting blood or needle.
• 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.
• Had participated in clinical trials of drugs and took research drugs within three months before screening.
• Smoke more than five cigarettes a day (including nicotine substitutes) or the same amount of tobacco products in the first three months of screening.
• Has history of drug abuse within 5 years before screening, or those who had used drugs within 3 months before screening.
• 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).
• 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.
• Positive urine drug screening in screening stage.
• Alcohol urine positive in screening stage.
• Nicotine positive in screening stage.
• With acute diseases in screening period.
• Had used any prescription, over-the-counter, vitamin products or Chinese herbal medicines within 14 days before enrollment.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Guangdong Kangda Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Interventions

Suramin; Sodium Chloride

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Naphthalenesulfonates; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• First Affiliated Hospital Zhejiang University

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianzhong Shentu, Ph.D.（Pharm）

CONTACT

0571 87236560; stjz@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind, placebo control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.（Pharm）

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 15, 2019
• Study Start: December 19, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2020
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)