LeukopeniaEarly Phase 1NCT04283695
To Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers
A Early Phase 1 study testing GX-I7 or [14C] GX-I7 in people with Leukopenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukopenia
- What is being tested?
- GX-I7 or [14C] GX-I7
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jul 2019to 1 May 2020
- Phase
- Early 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is willing and able to give informed consent after listening character of the clinical trial
- Must be 19-45 years of age, inclusive
- Weight 50-100kg, BMI 18-30kg/m2
- Subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values
- No clinical abnormality from ECG test
- Non-smoker (no smoking or no use of any product containing nicotine least for one month and negative from urine test)
Who cannot join
- Suspected or confirmed malignancy, or has malignancy history
- Any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (CNS or peripheral). respiratory system, endocrine (diabetes, hyperlipidemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, mental disorder, musculoskeletal disorder, immune system (rheumatoid arthritis, lupus etc), otorhinolaryngologic diseases
- Positive to HBsAg, hepatitis C virus (HCV) Ab and HIV Ab
- Are considering or scheduled to undergo any surgical or dental procedure during the study
- Administered other Investigational Product (IP) by attending other clinical study or biological equivalent study within recent 6 months
- Any Serious adverse drug reaction (SAR) against vaccines or antibiotics, any medical history with serious allergic diseases
Show all 15Show fewer
- Positive from urine drug screen or respiratory alcohol screen at medical screening
- History of alcohol, drug, or substance abuse in the past 12 months
- A heavy alchol consumer (>21 units/week, 1 unit = 10 g of pure alcohol) or Consumption of alcohol within 48 hours prior to hospitalization
- Medications with antacid, analgesic, herbal treatment, vitamin, mineral (except maximum 4 grams of acetaminophen) hormone, steroids, insulin, hypoglycemic drug or other hormone substitute within 14 days before administration
- Planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following IP administration
- Do not have veins suitable for cannulation or multiple venipunctures
- Previously donate whole blood within 60 days or component blood within 14 days
- Excessive consumption of foods containing grapefruits
- Any other factor that the Investigator thinks will increase subject risk with participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul
About this study
Official title: A Phase 1, Open-labeled, Single-dose, One-sequence, One-period, 3-part Study to Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers
Read the detailed description
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers To show ABA and Mass balance of GX-I7
- Conditions
- Leukopenia
- Being tested
- GX-I7 or [14C] GX-I7
- Medical subject headings
- Leukopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GX-I7 or [14C] GX-I7Drug
IM GX-I7 or IV/IM microdose of GX-I7
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | IM: GX-I7 60 µg/kg IV: [14C]-GX-I7 40 µg Receives: Drug: GX-I7 or [14C] GX-I7 |
| Part 2 | Experimental | IV: [14C]-GX-I7 40 µg Receives: Drug: GX-I7 or [14C] GX-I7 |
| Part 3 | Experimental | IM: GX-I7 60 µg/kg, [14C]-GX-I7 40 µg Receives: Drug: GX-I7 or [14C] GX-I7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity at feces,urine,blood to measure total recovery rate
radioactivity in nCi
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start3 Jul 2019
- Primary completion30 Aug 2019
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukopeniaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283695
- Sponsor's protocol ID
- Mab_GX_I7
- Status last verified
- Feb 2020
- First submitted
- 18 Nov 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-labeled, Single-dose, One-sequence, One-period, 3-part Study to Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04283695
- Acronym / sponsor ID
- Mab_GX_I7
- Conditions
- Leukopenia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers
Detailed description
A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers To show ABA and Mass balance of GX-I7
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: GX-I7 or [14C] GX-I7IM: GX-I7 60 µg/kg IV: [14C]-GX-I7 40 µg |
| Part 2 | Experimental | Drug: GX-I7 or [14C] GX-I7IV: [14C]-GX-I7 40 µg |
| Part 3 | Experimental | Drug: GX-I7 or [14C] GX-I7IM: GX-I7 60 µg/kg, [14C]-GX-I7 40 µg |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is willing and able to give informed consent after listening character of the clinical trial
- Must be 19-45 years of age, inclusive
- Weight 50-100kg, BMI 18-30kg/m2
- Subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values
- No clinical abnormality from ECG test
Key exclusion criteria (15 listed)
- Suspected or confirmed malignancy, or has malignancy history
- Any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (CNS or peripheral). respiratory system, endocrine (diabetes, hyperlipidemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, mental disorder, musculoskeletal disorder, immune system (rheumatoid arthritis, lupus etc), otorhinolaryngologic diseases
- Positive to HBsAg, hepatitis C virus (HCV) Ab and HIV Ab
- Are considering or scheduled to undergo any surgical or dental procedure during the study
- Administered other Investigational Product (IP) by attending other clinical study or biological equivalent study within recent 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GX-I7 or [14C] GX-I7IM GX-I7 or IV/IM microdose of GX-I7 | Drug | Part 1, Part 2, Part 3 |
Primary outcome
Total radioactivity at feces,urine,blood to measure total recovery rate
Time frame: 29 days
radioactivity in nCi
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GX-I7 or [14C] GX-I7 in people with Leukopenia, run by Seoul National University Hospital 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 Feb 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Total radioactivity at feces,urine,blood to measure total recovery rate (time frame: 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2020.