Healthy Male VolunteersEarly Phase 1NCT03014895
A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects
A Early Phase 1 study testing E3112 in people with Healthy Male Volunteers, run by EA Pharma Co., Ltd. at 1 site in Japan.
Trial summary
The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112. Read more about this study
- Who is it for?
- Ages 20 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- E3112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteJapan
- Study dates
- 25 Jan 2017to 22 Nov 2017
- 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 20 to 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Main Inclusion Criteria:
- Non-smoking, Japanese, male participants, ≥20 and <45 years old at the time of obtaining informed consent
- Have a Body Mass Index (BMI) ≥18.5 and <25.0 kilograms per meters squared (kg/m^2) at Screening
- Able to provide written informed consent of their free will
- Males who were given a full explanation of all the requirements of the protocol, and are willing and able to comply with them
Who cannot join
- Main Exclusion Criteria:
- Male and his partner who do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
- Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing.
- Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
- Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of study drug at Screening
- Any suspected clinically abnormal symptom or organ impairment that require medical treatment at Screening or Baseline
Show all 13Show fewer
- Receipt of vaccination within 4 weeks prior to dosing
- History of drug or alcohol dependency or abuse prior to Screening
- Intake of caffeinated beverages or food within 72 hours prior to dosing
- Use of prescription drugs within 4 weeks prior to dosing
- Intake of over-the-counter (OTC) medications within 2 weeks prior to dosing
- Male who is currently being enrolled in another clinical study or used any investigational drug or device in another clinical study within 16 weeks prior to dosing
- Male who underwent a blood transfusion within 12 weeks prior to dosing, who donate 400 milliliters (mL) or more of whole blood within 12 weeks prior to dosing, who donate 200 mL or more of whole blood within 4 weeks prior to dosing, or who made a component donation within 2 weeks prior to dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects
The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.
- Conditions
- Healthy Male Volunteers
- Being tested
- Placebo, E3112
- Keywords
- E3112, Pharmacokinetics, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Intravenous infusion
E3112Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Placebo | Placebo comparator | Intravenous placebo infusion Receives: Drug: Placebo |
| Cohort 1: E3112 | Experimental | Intravenous E3112 infusion Receives: Drug: E3112 |
| Cohort 2: Placebo | Placebo comparator | Intravenous placebo infusion Receives: Drug: Placebo |
| Cohort 2: E3112 | Experimental | Intravenous E3112 infusion Receives: Drug: E3112 |
| Cohort 3: Placebo | Placebo comparator | Intravenous placebo infusion Receives: Drug: Placebo |
| Cohort 3: E3112 | Experimental | Intravenous E3112 infusion Receives: Drug: E3112 |
| Cohort 4: Placebo | Placebo comparator | Intravenous placebo infusion Receives: Drug: Placebo |
| Cohort 4: E3112 | Experimental | Intravenous E3112 infusion Receives: Drug: E3112 |
| Cohort 5: Placebo | Placebo comparator | Intravenous placebo infusion Receives: Drug: Placebo |
| Cohort 5: E3112 | Experimental | Intravenous E3112 infusion Receives: Drug: E3112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax) of E3112
Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Measured: Days 1 to 4, 8, 14, and 28
Time to peak concentration (Tmax) of E3112
Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Measured: Days 1 to 4, 8, 14, and 28
Area under the curve (AUC)
AUC is the area under the curve in a plot of concentration of drug in blood plasma against time. AUC represents the total drug exposure over a defined period of time.
Measured: Days 1 to 4, 8, 14, and 28
Half-life of elimination (t1/2) of E3112
t1/2 is the time required for the concentration of the drug to reach half of its original value.
Measured: Days 1 to 4, 8, 14, and 28
Clearance of E3112
Clearance is defined as the rate of drug elimination divided by the plasma concentration of the drug.
Measured: Days 1 to 4, 8, 14, and 28
Volume of distribution (Vd) of E3112
Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.
Measured: Days 1 to 4, 8, 14, and 28
Secondary outcomes (7)
Number of participants with any serious adverse event and any non-serious adverse event
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
Measured: Days 1 to 28
Number of participants with an abnormal, clinically significant hematology parameter value
Clinical significance will be determined by the investigator.
Measured: Days 1 to 28
Number of participants with an abnormal, clinically significant blood chemistry parameter value
Clinical significance will be determined by the investigator.
Measured: Days 1 to 28
Number of participants with an abnormal, clinically significant urine value
Clinical significance will be determined by the investigator.
Measured: Days 1 to 28
Number of participants with an abnormal, clinically significant vital sign measurement
Clinical significance will be determined by the investigator.
Measured: Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement
Clinical significance will be determined by the investigator.
Measured: Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant physical examination measurement
Clinical significance will be determined by the investigator.
Measured: Baseline; Days 1 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start25 Jan 2017
- Primary completion12 Jun 2017
- Study completion22 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- EA Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014895
- Sponsor's protocol ID
- E3112/CP1
- Status last verified
- Jun 2018
- First submitted
- 6 Jan 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT03014895
- Acronym / sponsor ID
- E3112/CP1
- Conditions
- Healthy Male Volunteers
- Keywords
- E3112, Pharmacokinetics, Japanese
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 22 Nov 2017 (actual)
- First posted
- 9 Jan 2017 (estimated)
- 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.
The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Placebo | Placebo comparator | Drug: PlaceboIntravenous placebo infusion |
| Cohort 1: E3112 | Experimental | Drug: E3112Intravenous E3112 infusion |
| Cohort 2: Placebo | Placebo comparator | Drug: PlaceboIntravenous placebo infusion |
| Cohort 2: E3112 | Experimental | Drug: E3112Intravenous E3112 infusion |
| Cohort 3: Placebo | Placebo comparator | Drug: PlaceboIntravenous placebo infusion |
| Cohort 3: E3112 | Experimental | Drug: E3112Intravenous E3112 infusion |
| Cohort 4: Placebo | Placebo comparator | Drug: PlaceboIntravenous placebo infusion |
| Cohort 4: E3112 | Experimental | Drug: E3112Intravenous E3112 infusion |
| Cohort 5: Placebo | Placebo comparator | Drug: PlaceboIntravenous placebo infusion |
| Cohort 5: E3112 | Experimental | Drug: E3112Intravenous E3112 infusion |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoking, Japanese, male participants, ≥20 and <45 years old at the time of obtaining informed consent
- Have a Body Mass Index (BMI) ≥18.5 and <25.0 kilograms per meters squared (kg/m^2) at Screening
- Able to provide written informed consent of their free will
- Males who were given a full explanation of all the requirements of the protocol, and are willing and able to comply with them
Key exclusion criteria (13 listed)
- Male and his partner who do not agree to use a highly effective method of contraception throughout the entire study period, if he has reproductive capacity
- Male who had or has any malignant tumor, lymphoma, leukaemia, or lymphoproliferative disorders. Clinically significant illness that required medical treatment within 8 weeks or a clinically significant infection within 4 weeks prior to dosing.
- Evidence of disease that may influence the outcome of the study within 4 weeks prior to dosing
- Any history of surgical treatment that may affect pharmacokinetic (PK) profiles of study drug at Screening
- Any suspected clinically abnormal symptom or organ impairment that require medical treatment at Screening or Baseline
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 |
|---|---|---|
| PlaceboIntravenous infusion | Drug | Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo, Cohort 4: Placebo, Cohort 5: Placebo |
| E3112Intravenous infusion | Drug | Cohort 1: E3112, Cohort 2: E3112, Cohort 3: E3112, Cohort 4: E3112, Cohort 5: E3112 |
Primary outcome
Peak concentration (Cmax) of E3112
Time frame: Days 1 to 4, 8, 14, and 28
Cmax is the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Time to peak concentration (Tmax) of E3112
Time frame: Days 1 to 4, 8, 14, and 28
Tmax is the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Area under the curve (AUC)
Time frame: Days 1 to 4, 8, 14, and 28
AUC is the area under the curve in a plot of concentration of drug in blood plasma against time. AUC represents the total drug exposure over a defined period of time.
Half-life of elimination (t1/2) of E3112
Time frame: Days 1 to 4, 8, 14, and 28
t1/2 is the time required for the concentration of the drug to reach half of its original value.
Clearance of E3112
Time frame: Days 1 to 4, 8, 14, and 28
Clearance is defined as the rate of drug elimination divided by the plasma concentration of the drug.
Volume of distribution (Vd) of E3112
Time frame: Days 1 to 4, 8, 14, and 28
Vd is the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma.
7 secondary outcomes
Number of participants with any serious adverse event and any non-serious adverse event
Time frame: Days 1 to 28
Number of participants with an abnormal, clinically significant hematology parameter value
Time frame: Days 1 to 28
Number of participants with an abnormal, clinically significant blood chemistry parameter value
Time frame: Days 1 to 28
Number of participants with an abnormal, clinically significant urine value
Time frame: Days 1 to 28
Number of participants with an abnormal, clinically significant vital sign measurement
Time frame: Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant electrocardiogram (ECG) measurement
Time frame: Baseline; Days 1 to 28
Number of participants with an abnormal, clinically significant physical examination measurement
Time frame: Baseline; Days 1 to 28
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 14 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Healthy Male Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
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 E3112 in people with Healthy Male Volunteers, run by EA Pharma Co., Ltd. at 1 site in Japan.
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 5 inclusion and 13 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 14 Nov 2018. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
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?
Peak concentration (Cmax) of E3112 (time frame: Days 1 to 4, 8, 14, and 28). 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?
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 14 Nov 2018.