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出境医 / 临床实验 / A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers

A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers

Study Description
Brief Summary:
The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: GC4711 30mg Drug: GC4711 60mg Drug: GC4711 90mg Drug: GC4711 120mg Drug: Placebo Drug: GC4711 75mg Drug: GC4711 105mg Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers
Actual Study Start Date : March 19, 2019
Actual Primary Completion Date : March 4, 2020
Actual Study Completion Date : March 4, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: GC4711 30mg Drug: GC4711 30mg
single dose given via a 15 minute intravenous infusion
Experimental: GC4711 60mg Drug: GC4711 60mg
single dose given via a 15 minute intravenous infusion
Experimental: GC4711 90mg Drug: GC4711 90mg
single dose given via a 15 minute intravenous infusion
Experimental: GC4711 120mg Drug: GC4711 120mg
single dose given via a 15 minute intravenous infusion
Placebo Comparator: Placebo Drug: Placebo
single dose of normal saline given via a 15 minute intravenous infusion
Experimental: GC4711 75mg Drug: GC4711 75mg
single dose given via a 15 minute intravenous infusion
Experimental: GC4711 105mg Drug: GC4711 105mg
single dose given via a 15 minute intravenous infusion
Outcome Measures
Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities [ Time Frame: From randomization through study completion (estimated up to 3 days) ]
    Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy men and women between 18 and 50 years
  2. Subjects who provide written informed consent
  3. Body Mass Index (BMI) of 18 to 32 kg/m2 and weighing at least 50 kg
  4. Subjects in general good health
  5. Blood pressure and pulse within normal limits
  6. Male subjects must practice effective contraception

  7. Female subjects must:

    • Have a negative serum pregnancy test during
    • Be non-lactating;
    • Be at least 2 years postmenopausal, surgically sterile, or practicing effective contraception.

Exclusion Criteria:

  1. History of clinically significant illness or medical history which would preclude them from the study.
  2. Known contraindication, hypersensitivity and/or allergy to study drugs
  3. Use of any prescription or over-the-counter medication within one week prior to study drug administration
  4. Anticipated need for any medication during the study
  5. Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors
  6. Use of other drugs that may, in the judgment of the Investigator, create a risk for a precipitous decrease in blood pressure
  7. Presence of orthostatic hypotension at screening
  8. Use of any vitamin or mineral supplement 24 hours before dosing or throughout study
  9. Positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
  10. Known history of substance abuse, drug addiction, or alcoholism within 3 years
  11. Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours before the administration of study drug and throughout the the study;
  12. Positive drug and alcohol toxicology screens during Screening
  13. History of smoking or any use of a tobacco product within 6 months
  14. Donation of blood or blood products within 30 days before Baseline and throughout the study;
  15. Mentally unstable or incapable of being compliant with the protocol
  16. Receipt of an investigational test substance within 3 months before the administration of study drugs, or anticipated receiving any study drugs
  17. Subject has previously participated in this study, or in a prior Galera study
Contacts and Locations

Locations
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Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia
Sponsors and Collaborators
Galera Therapeutics, Inc.
Investigators
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Study Chair: Jon Holmlund, MD Galera Therapeutics, Inc.
Tracking Information
First Submitted Date  ICMJE November 30, 2018
First Posted Date  ICMJE December 3, 2018
Last Update Posted Date August 14, 2020
Actual Study Start Date  ICMJE March 19, 2019
Actual Primary Completion Date March 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018) 		Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities [ Time Frame: From randomization through study completion (estimated up to 3 days) ]
Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers
Brief Summary The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: GC4711 30mg
    single dose given via a 15 minute intravenous infusion
  • Drug: GC4711 60mg
    single dose given via a 15 minute intravenous infusion
  • Drug: GC4711 90mg
    single dose given via a 15 minute intravenous infusion
  • Drug: GC4711 120mg
    single dose given via a 15 minute intravenous infusion
  • Drug: Placebo
    single dose of normal saline given via a 15 minute intravenous infusion
  • Drug: GC4711 75mg
    single dose given via a 15 minute intravenous infusion
  • Drug: GC4711 105mg
    single dose given via a 15 minute intravenous infusion
Study Arms  ICMJE
  • Experimental: GC4711 30mg
    Intervention: Drug: GC4711 30mg
  • Experimental: GC4711 60mg
    Intervention: Drug: GC4711 60mg
  • Experimental: GC4711 90mg
    Intervention: Drug: GC4711 90mg
  • Experimental: GC4711 120mg
    Intervention: Drug: GC4711 120mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: GC4711 75mg
    Intervention: Drug: GC4711 75mg
  • Experimental: GC4711 105mg
    Intervention: Drug: GC4711 105mg
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2020) 		70
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2018) 		40
Actual Study Completion Date  ICMJE March 4, 2020
Actual Primary Completion Date March 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy men and women between 18 and 50 years
  2. Subjects who provide written informed consent
  3. Body Mass Index (BMI) of 18 to 32 kg/m2 and weighing at least 50 kg
  4. Subjects in general good health
  5. Blood pressure and pulse within normal limits
  6. Male subjects must practice effective contraception

  7. Female subjects must:

    • Have a negative serum pregnancy test during
    • Be non-lactating;
    • Be at least 2 years postmenopausal, surgically sterile, or practicing effective contraception.

Exclusion Criteria:

  1. History of clinically significant illness or medical history which would preclude them from the study.
  2. Known contraindication, hypersensitivity and/or allergy to study drugs
  3. Use of any prescription or over-the-counter medication within one week prior to study drug administration
  4. Anticipated need for any medication during the study
  5. Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors
  6. Use of other drugs that may, in the judgment of the Investigator, create a risk for a precipitous decrease in blood pressure
  7. Presence of orthostatic hypotension at screening
  8. Use of any vitamin or mineral supplement 24 hours before dosing or throughout study
  9. Positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
  10. Known history of substance abuse, drug addiction, or alcoholism within 3 years
  11. Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours before the administration of study drug and throughout the the study;
  12. Positive drug and alcohol toxicology screens during Screening
  13. History of smoking or any use of a tobacco product within 6 months
  14. Donation of blood or blood products within 30 days before Baseline and throughout the study;
  15. Mentally unstable or incapable of being compliant with the protocol
  16. Receipt of an investigational test substance within 3 months before the administration of study drugs, or anticipated receiving any study drugs
  17. Subject has previously participated in this study, or in a prior Galera study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03762031
Other Study ID Numbers  ICMJE GTI-4711-002
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 Galera Therapeutics, Inc.
Study Sponsor  ICMJE Galera Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jon Holmlund, MD Galera Therapeutics, Inc.
PRS Account Galera Therapeutics, Inc.
Verification Date August 2020

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

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