Acute Radiation SyndromePhase 1NCT03585803

A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011

A Phase 1 study of Acute Radiation Syndrome, run by Intron Biotechnology, 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.

Trial summary

This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers. Read more about this study

Who is it for?: Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Acute Radiation Syndrome
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteSouth Korea
Study dates: 11 Jun 2018to 28 Nov 2019
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 19 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

A male whose age is between 19 and 55 years of age
A person whose body mass index is between 18.5 and 27 kg/m2 at screening
A person who has the ability and willingness to participate in the clinical trial
A person who voluntarily agrees with the clinical trial after hearing and fully understanding the detailed explanation of this clinical trial

Who cannot join

A person who has a clinically significant disease or history of liver, kidney, neuropsychiatry, immune system, respiratory system, endocrine system, hematology*oncology system, cardiovascular system, etc.(In the case of liver disease items, it includes subjects who have hepatitis virus)
A person who has clinical history of hypersensitivity reactions to the major components or constituents of investigational product or other clinically significant hypersensitivity reactions to drugs or foods, or those with allergic diseases requiring treatment
A person with infectious disease or severe trauma within 21 days of the randomization date
A person whose serum AST, ALT or γ-GT levels exceed 1.5 times the upper limit of the reference range at screening
A person whose QTcF on the electrocardiogram exceeds 430 msec or who has a clinically significant abnormal rhythm at screening
A person with a glomerular filtration rate less than 60 mL/min/1.73 m2 calculated from serum creatinine at screening

Show all 17Show fewer

A person with a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 60 mmHg, or greater than 100 mmHg at screening
A person with thrombocytopenia or coagulopathy which should not be given intramuscular injection
A person whose weekly average drinking amount exceeds 140g of alcohol per week
A person whose daily average smoking amount exceeds 10 per day
A person who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the investigational product within 14 days of the injection
A person who has the history of substance abuse or positive urine screening test
A person who have received a investigational product or a bioequivalence study drug within at least 90 days prior to the randomization
A person who donated whole blood within 60 days before the randomization, or donated components of blood within 30 days
A person who dose not have a medically approved contraceptive during the trial and has a plan to provide sperm
A person who has clinically significant abnormalities from clinical laboratory test
A person who is deemed ineligible for clinical trials by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Samsung Medical Center
Gangnam-gu, Seoul, 06351

Other trials in South Korea

About this study

Official title: A Dose Blocked-Randomized, Single-Blind, Placebo-Controlled and Dose-Escalation Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011 After Intramuscular Administration in Healthy Adult Volunteers

This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.

Conditions: Acute Radiation Syndrome
Being tested: KMRC011 5μg or Placebo, KMRC011 10μg or Placebo, KMRC011 15μg or Placebo, KMRC011 20μg or Placebo, KMRC011 25μg or Placebo
Medical subject headings: Acute Radiation Syndrome

What participants receive

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

KMRC011 5μg or PlaceboDrug
Also called Cohort 1
Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml
KMRC011 10μg or PlaceboDrug
Also called Cohort 2
Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml
KMRC011 15μg or PlaceboDrug
Also called Cohort 3
Intramuscular Injection of KMRC011 15μg or Placebo(Normal Saline) 0.3ml
KMRC011 20μg or PlaceboDrug
Also called Cohort 4
Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.4ml
KMRC011 25μg or PlaceboDrug
Also called Cohort 5
Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.5ml

Study groups in NCT03585803
Study group	Role	What they receive
KMRC011 5μg or Placebo	Other	Cohort 1 Receives: Drug: KMRC011 5μg or Placebo
KMRC011 10μg or Placebo	Other	Cohort 2 Receives: Drug: KMRC011 10μg or Placebo
KMRC011 15μg or Placebo	Other	Cohort 3 Receives: Drug: KMRC011 15μg or Placebo
KMRC011 20μg or Placebo	Other	Cohort 4 Receives: Drug: KMRC011 20μg or Placebo
KMRC011 25μg or Placebo	Other	Cohort 5 Receives: Drug: KMRC011 25μg or Placebo

What is being measured

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

Number of subjects with treatment-emergent adverse event or adverse drug reaction
Measured: Up to 7±1 days after injection
Number of subjects with clinically significant changes in hematology test result after injection
Measured: Up to 7±1 days after injection
Number of subjects with clinically significant changes in blood chemistry test result after injection
Measured: Up to 7±1 days after injection
Number of subjects with clinically significant changes in urinalysis test result after injection
Measured: Up to 7±1 days after injection
Number of subjects with clinically significant changes in blood coagulation test result after injection
Measured: Up to 7±1 days after injection
Number of subjects with clinically significant changes in ECG (Electrocardiogram) after injection
Measured: Up to 7±1 days after injection
Number of subjects with clinically significant changes in vital sign after injection
Measured: Up to 7±1 days after injection
Number of subjects with clinically significant physical abnormality after injection
Measured: Up to 7±1 days after injection
Maximum serum concentration (Cmax) of KMRC011
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Time of the maximum serum concentration (Tmax) of KMRC011
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Area under the serum concentration versus time curve, from time 0 to the last measurable concentration (AUC0-t) of KMRC011
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of KMRC011
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Percentage of AUCinf due to extrapolation from time of last measurable concentration to infinity (AUCextra) of KMRC011
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Apparent clearance (CL/F) of KMRC011
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Apparent volume of distribution (Vd/F) of KMRC011
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Terminal half-life (t1/2) of KMRC011
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Maximum effect over the time span specified (Emax) of G-CSF
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Maximum effect over the time span specified (Emax) of IL-6
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of G-CSF
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of IL-6
Measured: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose

Secondary outcomes (1)

Maximum Tolerated Dose (MTD) of KMRC011
A dose that is one level lower than the dose which Dose Limiting Toxicity (DLT) incidence is 33% or more is determined as a Maximum Tolerated Dose (MTD). If the Dose Limiting Toxicity (DLT) incidence is lower than 33% at all doses level, we conclude Maximum Tolerated Dose (MTD) cannot be determined.
Measured: Until the study completion, approximately up to 35 weeks

Timeline

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

11 Jun 201828 Nov 2019

First posted13 Jul 2018
Study start11 Jun 2018
Primary completion11 Sep 2019
Study completion28 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Radiation SyndromeStudies of the same condition, open and under way.
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: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03585803
Sponsor's protocol ID: KMRC011-01
Status last verified: Jan 2021
First submitted: 3 Jun 2018
Last updated: 1 Feb 2021
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 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Blocked-Randomized, Single-Blind, Placebo-Controlled and Dose-Escalation Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011 After Intramuscular Administration in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT03585803
Acronym / sponsor ID: KMRC011-01
Conditions: Acute Radiation Syndrome
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Intron Biotechnology, Inc.Industry (pharma, biotech, devices)
Study start: 11 Jun 2018 (actual)
Primary completion: 11 Sep 2019 (actual)
Study completion: 28 Nov 2019 (actual)
First posted: 13 Jul 2018 (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.

This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
KMRC011 5μg or Placebo	Other	Drug: KMRC011 5μg or PlaceboCohort 1
KMRC011 10μg or Placebo	Other	Drug: KMRC011 10μg or PlaceboCohort 2
KMRC011 15μg or Placebo	Other	Drug: KMRC011 15μg or PlaceboCohort 3
KMRC011 20μg or Placebo	Other	Drug: KMRC011 20μg or PlaceboCohort 4
KMRC011 25μg or Placebo	Other	Drug: KMRC011 25μg or PlaceboCohort 5

Who may qualify

Ages: 19 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

A male whose age is between 19 and 55 years of age
A person whose body mass index is between 18.5 and 27 kg/m2 at screening
A person who has the ability and willingness to participate in the clinical trial
A person who voluntarily agrees with the clinical trial after hearing and fully understanding the detailed explanation of this clinical trial

Key exclusion criteria (17 listed)

A person who has a clinically significant disease or history of liver, kidney, neuropsychiatry, immune system, respiratory system, endocrine system, hematology*oncology system, cardiovascular system, etc.(In the case of liver disease items, it includes subjects who have hepatitis virus)
A person who has clinical history of hypersensitivity reactions to the major components or constituents of investigational product or other clinically significant hypersensitivity reactions to drugs or foods, or those with allergic diseases requiring treatment
A person with infectious disease or severe trauma within 21 days of the randomization date
A person whose serum AST, ALT or γ-GT levels exceed 1.5 times the upper limit of the reference range at screening
A person whose QTcF on the electrocardiogram exceeds 430 msec or who has a clinically significant abnormal rhythm at screening

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
KMRC011 5μg or PlaceboAlso: Cohort 1Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml	Drug	KMRC011 5μg or Placebo
KMRC011 10μg or PlaceboAlso: Cohort 2Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml	Drug	KMRC011 10μg or Placebo
KMRC011 15μg or PlaceboAlso: Cohort 3Intramuscular Injection of KMRC011 15μg or Placebo(Normal Saline) 0.3ml	Drug	KMRC011 15μg or Placebo
KMRC011 20μg or PlaceboAlso: Cohort 4Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.4ml	Drug	KMRC011 20μg or Placebo
KMRC011 25μg or PlaceboAlso: Cohort 5Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.5ml	Drug	KMRC011 25μg or Placebo

Primary outcome

Number of subjects with treatment-emergent adverse event or adverse drug reaction
Time frame: Up to 7±1 days after injection
Number of subjects with clinically significant changes in hematology test result after injection
Time frame: Up to 7±1 days after injection
Number of subjects with clinically significant changes in blood chemistry test result after injection
Time frame: Up to 7±1 days after injection
Number of subjects with clinically significant changes in urinalysis test result after injection
Time frame: Up to 7±1 days after injection
Number of subjects with clinically significant changes in blood coagulation test result after injection
Time frame: Up to 7±1 days after injection
Number of subjects with clinically significant changes in ECG (Electrocardiogram) after injection
Time frame: Up to 7±1 days after injection
Number of subjects with clinically significant changes in vital sign after injection
Time frame: Up to 7±1 days after injection
Number of subjects with clinically significant physical abnormality after injection
Time frame: Up to 7±1 days after injection
Maximum serum concentration (Cmax) of KMRC011
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Time of the maximum serum concentration (Tmax) of KMRC011
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Area under the serum concentration versus time curve, from time 0 to the last measurable concentration (AUC0-t) of KMRC011
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of KMRC011
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Percentage of AUCinf due to extrapolation from time of last measurable concentration to infinity (AUCextra) of KMRC011
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Apparent clearance (CL/F) of KMRC011
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Apparent volume of distribution (Vd/F) of KMRC011
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Terminal half-life (t1/2) of KMRC011
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Maximum effect over the time span specified (Emax) of G-CSF
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Maximum effect over the time span specified (Emax) of IL-6
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of G-CSF
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of IL-6
Time frame: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose

1 secondary outcome

Maximum Tolerated Dose (MTD) of KMRC011
Time frame: Until the study completion, approximately up to 35 weeks

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.

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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.

Jung-Ryul Kim, MD, PhD principal investigator

Samsung Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Acute Radiation Syndrome, run by Intron Biotechnology, 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 4 inclusion and 17 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 1 Feb 2021. 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?

Number of subjects with treatment-emergent adverse event or adverse drug reaction (time frame: Up to 7±1 days after injection). The study lists 20 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 NCT03585803.

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 1 Feb 2021.