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HealthyPhase 1GX-E2-P1NCT02291991

Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects

A Phase 1 study testing GX-E2 in people with Healthy, run by Genexine, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, placebo controlled, single dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects. Read more about this study

Who is it for?
Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
GX-E2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
Nov 2014to Jan 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Written informed consent
  • Male subjects 20 to 55 years old
  • Adequate body weigth and BMI(19 ≤ BMI ≤ 27, 60.0kg ≤ body weigth ≤ 90.0kg)
  • The subject doesn't have a clinically significant abnormal laboratory value and/or clinically significant unstable medical or disease history.
  • Are eligible for the study hemoglobin data(12.0g/dL ≤ Hb ≤ 16.5g/dL) (Data is checked per 2 weeks within 28 days)
  • Adequate transferrin saturation, serum ferritin within 28 days
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  • Adequate folate within 28 days
  • Adequate vitamin B12 within 28 days
  • Adequate WBC count (≥ 3.0 X 1000 µL)
  • Adequate PLT count(≥ 140 X 1000 µL)
  • nonsmoker or smoker smoked under 10 cigarettes a day

Who cannot join

  • The subject has a clinically significant abnormal allergy including medical allergy.
  • The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease
  • Subject with a previous experience in i.v. administration of EPO, darbepoetin, other EPO supplying proteins, immunoglobulin and iron drugs
  • Subject with a hypersensitivity against EPO, darbepoetin and supplementary iron drugs
  • Subject with a condition of hemoglobinopathy (e.g. sickle-cell disease and thalassemia)
  • Subject showing following systolic and diastolic parameters at sitting position after 3 minutes of resting: lower than 90 mmHg or higher than 140mmHg of systolic blood pressure and lower than 50 mmHg or higher than 90mmHg of diastolic blood pressure
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  • Subject with chronic and uncontrollable symptoms of inflammatory disease (e.g. rheumatoid arthritis and systemic lupous erythematousus)
  • Subject with the exceeding level of C-reactive protein more than 4 mg/dL before 2 weeks of IP administration
  • History of drug prior to screening or urine drug testing is positive (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)
  • Subject who has administered with a prescribed drug and oriental or herbal medicine in 2 weeks before IP administration, and who has administered with a general pharmaceutical and vitamin in 1 week before IP administration
  • Subject who has enrolled in other clinical trials of IP or approved drug within 8 weeks before IP administration
  • Subject with a history of fever at body temperature more than 38°C in a week before IP administration
  • History of epileptic convulsion within 6 months
  • Subject who is positive in HIV, HBsAg, HCV antibody test
  • Subject with a regular alcohol consumption more than 21 unit, and who is unable to quit drinking during the period of clinical trial
  • Subject who donated or lost more than 400mL of blood within 8 weeks prior to first dose
  • Subject who is treated with investigational products.
  • Subject with a longer length of spleen more than 16cm via upper abdominal ultrasound during the screening
  • Subject who is considered as inappropriate for participation by Investigator based on various lab results
  • Subject who plans to be pregnant or at least is unable to apply authorized contraceptive methods (e.g. sterilization operation, the use of contraceptive devices)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind Placebo Controlled, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 After Single Intravenous Administration in Healthy Subjects

This is a randomized, placebo controlled, single dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.

Read the detailed description

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of GX-E2 when given as single dose (GX-E2 8 ug/kg) to healthy male subjects. Additionally, Immunogenecity will be evaluated to investigate antibody production.

Conditions
Healthy
Being tested
GX-E2
Keywords
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenecity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX-E2Drug

    Also called GC1113

    Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

  • GX-E2Drug

    Also called GC1113

    Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

Study groups in NCT02291991
Study groupRoleWhat they receive
Group AExperimentalDrug : GX-E2 - Intravenously injection once day at dose 8 ug/kg Drug : Placebo (1 subject : GX-E2, 1 subject : Placebo) Subjects in group A will be injected drug, So we observe safety. After three days, Subject in group B will be injected drug.
Receives: Drug: GX-E2
Group BExperimentalDrug : GX-E2 - Intravenously injection once day at dose 8 ug/kg Drug : Placebo (7 subjects : GX-E2, 1 subject : Placebo)
Receives: Drug: GX-E2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pharmacokinetics as measured by Cmax

    Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"

    Measured: Day1 - 29

  2. pharmacokinetics as measured by Cmax AUC(0-tlast)

    Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"

    Measured: Day1 - 29

  3. pharmacokinetics as measured by AUCing

    Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"

    Measured: Day1 - 29

  4. pharmacokinetics as measured by Tmax

    Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"

    Measured: Day1 - 29

  5. pharmacokinetics as measured by t1/2

    Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"

    Measured: Day1 - 29

  6. pharmacokinetics as measured by CL/F

    Measures "Cmax, AUC(0-tlast), AUCing, Tmax, t1/2 and CL/F after single dose of 8ug/kg GX-E2"

    Measured: Day1 - 29

Secondary outcomes (4)

  1. pharmacodynamics as measured by Hemoglobin

    Hemoglobin, Reticulocyte count, Reticulocyte hemoglobin contents

    Measured: Day1 - 29

  2. pharmacodynamics as measured by Reticulocyte count

    Measured: Day1 - 29

  3. pharmacodynamics as measured by Reticulocyte hemoglobin contents

    Measured: Day1 - 29

  4. Safety and Tolerability of GX-E2 as checked immunogenecity

    Measured: Day1 - 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02291991
Sponsor's protocol ID
GX-E2-P1
Acronym
GX-E2-P1
Status last verified
Jan 2015
First submitted
30 Oct 2014
Last updated
29 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GX-E2 in people with Healthy, run by Genexine, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pharmacokinetics as measured by Cmax (time frame: Day1 - 29). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02291991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015.

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