Healthy Male ParticipantsPhase 1NCT03922633

A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants

A Phase 1 study testing E3112 in people with Healthy Male Participants, run by EA Pharma Co., Ltd. at 1 site in Japan.

Completed

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

Trial summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants. 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 Participants
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: 24 participants
Where: 1 siteJapan
Study dates: 22 Apr 2019to 1 Oct 2020
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 44 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Non-smoking Japanese males aged 20 to 44 years at the time of written, informed consent
Body Mass Index (BMI) at screening is 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2)
Written, informed consent to participate in the study based on the participant's own free will
Willing and able to comply with the requirements in the study after being fully informed of the requirements

Who cannot join

Male participants with reproductive potential who and whose partner do not agree to practice medically appropriate contraception (Note: throughout the study)
A history or complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disorder, a clinically significant disease requiring treatments within 8 weeks before the investigational product treatment, or a history of a clinically significant infection within 4 weeks before the investigational product treatment
With a psychiatric, digestive, hepatic, renal, respiratory, endocrine, hematologic, neural, or cardiovascular disease within 4 weeks before the investigational product treatment, a congenital metabolic abnormality, or otherwise a disease that may affect the drug assessments
With a surgical history (e.g., resection of the liver, kidney, or digestive tract, etc.) at screening that may affect the pharmacokinetics of the investigational product
Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
Testing positive for human immunodeficiency virus (HIV) at screening

Show all 12Show fewer

A positive response to a qualitative test for hepatitis B virus surface antigen (HBs antigen), hepatitis B virus core antigen (HBc) antibody, hepatitis C virus (HCV) antibody, or syphilis
Use of a prescription drug within 4 weeks before the investigational product treatment
Use of an over-the-counter drug within 2 weeks before the investigational product treatment
Receiving a vaccine within 4 weeks before the investigational product treatment
Ongoing participation in another clinical study or use of an investigational product or device within 16 weeks before the investigational product treatment while participating in another clinical study
Receiving blood transfusion within 12 weeks before the investigational product treatment, providing a whole-blood sample of 400 millilitre (mL) or more between 12 to 4 weeks before the investigational product treatment or a whole-blood sample of 200 mL or more within 4 weeks before the investigational product treatment, or giving blood components by pheresis within 2 weeks before the investigational product treatment

Trial locations and contacts

1 site in 1 country.

Japan1 site

EA Pharma Trial Site
Higashi, Fukuoka

Other trials in Japan

About this study

Official title: A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants.

Conditions: Healthy Male Participants
Being tested: E3112, Placebo
Keywords: E3112, Phase 1, Pharmacokinetics, Japanese

What participants receive

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

E3112Drug
Intravenous infusion.
PlaceboOther
Intravenous infusion.

Study groups in NCT03922633
Study group	Role	What they receive
Cohort 1 Group A: E3112 + Placebo	Experimental	E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Receives: Drug: E3112; Other: Placebo
Cohort 1 Group B: Placebo + E3112	Experimental	Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Receives: Drug: E3112; Other: Placebo
Cohort 2 Group A: E3112 + Placebo	Experimental	E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Receives: Drug: E3112; Other: Placebo
Cohort 2 Group B: Placebo + E3112	Experimental	Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Receives: Drug: E3112; Other: Placebo
Cohort 3 Group A: E3112 + Placebo	Experimental	E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Receives: Drug: E3112; Other: Placebo
Cohort 3 Group B: Placebo + E3112	Experimental	Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Receives: Drug: E3112; Other: Placebo
Cohort 4 Group A: E3112 + Placebo	Experimental	E3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Receives: Drug: E3112; Other: Placebo
Cohort 4 Group B: Placebo + E3112	Experimental	Placebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages. Receives: Drug: E3112; Other: Placebo

What is being measured

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

Serum Concentrations of E3112
Measured: Day 1: 0-24 hours; Day 8: 0-24 hours
Change from Baseline in Serum Concentration of E3112
Measured: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours
Area Under the Concentration-time Curve (AUC 0-t) of E3112
AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.
Measured: Day 1: 0-24 hours; Day 8: 0-24 hours
Area Under the Concentration-time Curve (AUC∞) of E3112
AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.
Measured: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours
Clearance (CL) of E3112
CL is defined as the rate of drug elimination divided by the plasma concentration of the drug.
Measured: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours

Secondary outcomes (9)

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Hematology parameter value
Measured: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value
Measured: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Urine Value
Measured: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Vital Signs
Measured: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Electrocardiogram (ECG)
Measured: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Physical Findings
Measured: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Ophthalmological Findings
Measured: Day 1 to Day 43
Percentage of Participants with Serum Anti-E3112 Antibodies
Measured: Day 1 to Day 43

Timeline

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

22 Apr 20191 Oct 2020

First posted22 Apr 2019
Study start22 Apr 2019
Primary completion20 May 2020
Study completion1 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Male ParticipantsStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03922633
Sponsor's protocol ID: E3112-CP2
Status last verified: Mar 2020
First submitted: 16 Apr 2019
Last updated: 15 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Male Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Clinical Study of a Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT03922633
Acronym / sponsor ID: E3112-CP2
Conditions: Healthy Male Participants
Keywords: E3112, Phase 1, Pharmacokinetics, Japanese
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 Apr 2019 (actual)
Primary completion: 20 May 2020 (actual)
Study completion: 1 Oct 2020 (actual)
First posted: 22 Apr 2019 (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.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after a single intravenous dose of E3112 in Japanese healthy adult male participants.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Cohort 1 Group A: E3112 + Placebo	Experimental	Drug: E3112, Other: PlaceboE3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
Cohort 1 Group B: Placebo + E3112	Experimental	Drug: E3112, Other: PlaceboPlacebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
Cohort 2 Group A: E3112 + Placebo	Experimental	Drug: E3112, Other: PlaceboE3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
Cohort 2 Group B: Placebo + E3112	Experimental	Drug: E3112, Other: PlaceboPlacebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
Cohort 3 Group A: E3112 + Placebo	Experimental	Drug: E3112, Other: PlaceboE3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
Cohort 3 Group B: Placebo + E3112	Experimental	Drug: E3112, Other: PlaceboPlacebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
Cohort 4 Group A: E3112 + Placebo	Experimental	Drug: E3112, Other: PlaceboE3112 intravenous infusion in treatment stage 1 followed by placebo intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.
Cohort 4 Group B: Placebo + E3112	Experimental	Drug: E3112, Other: PlaceboPlacebo intravenous infusion in treatment stage 1 followed by E3112 intravenous infusion in treatment stage 2. A washout period of 7 days will be maintained between the two treatment stages.

Who may qualify

Ages: 20 to 44 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Non-smoking Japanese males aged 20 to 44 years at the time of written, informed consent
Body Mass Index (BMI) at screening is 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2)
Written, informed consent to participate in the study based on the participant's own free will
Willing and able to comply with the requirements in the study after being fully informed of the requirements

Key exclusion criteria (12 listed)

Male participants with reproductive potential who and whose partner do not agree to practice medically appropriate contraception (Note: throughout the study)
A history or complication of malignant tumor, lymphoma, leukemia, or lymphoproliferative disorder, a clinically significant disease requiring treatments within 8 weeks before the investigational product treatment, or a history of a clinically significant infection within 4 weeks before the investigational product treatment
With a psychiatric, digestive, hepatic, renal, respiratory, endocrine, hematologic, neural, or cardiovascular disease within 4 weeks before the investigational product treatment, a congenital metabolic abnormality, or otherwise a disease that may affect the drug assessments
With a surgical history (e.g., resection of the liver, kidney, or digestive tract, etc.) at screening that may affect the pharmacokinetics of the investigational product
Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening or physical findings, vital signs, electrocardiogram findings, or laboratory values 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
E3112Intravenous infusion.	Drug	Cohort 1 Group A: E3112 + Placebo, Cohort 1 Group B: Placebo + E3112, Cohort 2 Group A: E3112 + Placebo, Cohort 2 Group B: Placebo + E3112, Cohort 3 Group A: E3112 + Placebo, Cohort 3 Group B: Placebo + E3112, Cohort 4 Group A: E3112 + Placebo, Cohort 4 Group B: Placebo + E3112
PlaceboIntravenous infusion.	Other	Cohort 1 Group A: E3112 + Placebo, Cohort 1 Group B: Placebo + E3112, Cohort 2 Group A: E3112 + Placebo, Cohort 2 Group B: Placebo + E3112, Cohort 3 Group A: E3112 + Placebo, Cohort 3 Group B: Placebo + E3112, Cohort 4 Group A: E3112 + Placebo, Cohort 4 Group B: Placebo + E3112

Primary outcome

Serum Concentrations of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Change from Baseline in Serum Concentration of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
Peak Concentration (Cmax) of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
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: Day 1: 0-24 hours; Day 8: 0-24 hours
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 Concentration-time Curve (AUC 0-t) of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
AUC 0-t is area under the concentration-time curve from time 0 to time of last quantifiable concentration for E3112.
Area Under the Concentration-time Curve (AUC∞) of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
AUC∞ is area under the concentration-time curve from time 0 to infinity of E3112.
Half-life of Elimination (t1/2) of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
t1/2 is the time required for the concentration of the drug to reach half of its original value.
Clearance (CL) of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
CL is defined as the rate of drug elimination divided by the plasma concentration of the drug.
Volume of Distribution (Vd) of E3112
Time frame: Day 1: 0-24 hours; Day 8: 0-24 hours
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.

9 secondary outcomes

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Hematology parameter value
Time frame: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Clinical Chemistry Parameter Value
Time frame: Day 1 to Day 43
Number of Participants with an Abnormal, Clinically Significant Urine Value
Time frame: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Vital Signs
Time frame: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Electrocardiogram (ECG)
Time frame: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Physical Findings
Time frame: Day 1 to Day 43
Number of Participants with Clinically Significant Change in Ophthalmological Findings
Time frame: Day 1 to Day 43
Percentage of Participants with Serum Anti-E3112 Antibodies
Time frame: Day 1 to Day 43

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 15 Mar 2021.
Individual participant dataSharing planned: No

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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 Phase 1 study testing E3112 in people with Healthy Male Participants, 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 4 inclusion and 12 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 15 Mar 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 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. 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?

Serum Concentrations of E3112 (time frame: Day 1: 0-24 hours; Day 8: 0-24 hours). The study lists 9 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 NCT03922633.

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 15 Mar 2021.