Healthy Adult MalePhase 1NCT07185113
A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects
A Phase 1 study testing GEn-1124 in people with Healthy Adult Male, run by GEn1E Lifesciences at 1 site in New Zealand.
Trial summary
The goal of this clinical trial is to determine the pharmacokinetics (how the body interacts with administered substances for the entire duration of exposure) of Gen-1124 in an oral formulation (taken by mouth) in healthy volunteers. It will also learn about the safety of Gen-1124. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- GEn-1124
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNew Zealand
- Study dates
- 29 Oct 2025to 4 Nov 2025
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects;
- Between 18 and 55 years of age;
- Provide a signed EC-approved consent form;
- Generally healthy, in the opinion of the Investigator;
- Body Mass Index (BMI) 18 to 32 kg/m^2;
- Creatinine clearance with in specific parameter;
- Using method of contraception;
- Willing and able to comply with protocol requirements for the duration of the study.
Who cannot join
- Subjects taking prohibited medication;
- Subjects with a history or presence of clinically significant medical or psychiatric disease;
- Subjects who have regularly used nicotine-containing products ;
- Subjects who have used caffeine-containing products;
- Subjects who are unable to comply with eating a standardized meal during the study;
- Subjects with a hospital admission or major surgery within 30 days prior to Screening;
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- Subjects with a plasma donation within 7 days prior to Screening;
- Subjects who have not abstained from alcoholic beverages/alcohol-containing products at least 72 hours prior to first dose, or plan to consume them at any time through completion of the Follow-up Visit;
- Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit;
- Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening;
- Subjects who are employees of the study unit or their family members, students who are working in the study unit, or family members of the Investigator or Sponsor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Dose, Open-label Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects
The goal of this clinical trial is to determine the pharmacokinetics (how the body interacts with administered substances for the entire duration of exposure) of Gen-1124 in an oral formulation (taken by mouth) in healthy volunteers. It will also learn about the safety of Gen-1124. The main questions it aims to answer are:
- How does Gen-1124 interact with a human body?
Researchers will look at how Gen-1124 interacts with the body and what side effects it may cause.
Participants will:
- Take Gen-1124 for a single dose
- Remain in clinic for 2 days for checkups and tests
- Recieve a phone call for a checkup 3 and 7 days after the single dose
Read the detailed description
Approximately 6 healthy male subjects who meet all eligibility criteria will be dosed.
There will be one single dose group of subjects dosed under fed (standardized meal) conditions.
Screening will be initiated up to 28 days before dosing. A follow-up visit will be completed approximately 7 days after dosing. Thus, total duration of subject participation in the study, excluding the Screening visit, will be approximately 8 days.
The incidence of adverse events from the time of informed consent through the final follow-up visit (end of study). This will be based on the results of:
- Physical exams,
- Electrocardiography (ECG) results,
- Clinical laboratory results,
- Vital signs,
- Concomitant medications. Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods.
- Conditions
- Healthy Adult Male
- Being tested
- GEn-1124
- Keywords
- GEn-1124, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEn-1124Drug
GEn-1124 will be administered to one single dose group of subjects dosed under fed (standardized meal) conditions. GEn-1124 will be administered as an oral capsule formulation containing GEn-1124.
| Study group | Role | What they receive |
|---|---|---|
| Single oral dose in healthy male volunteers | Experimental | There will be only one group of participants that will receive a single oral capsule dose, administered under fed conditions following a standardized meal. Receives: Drug: GEn-1124 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Endpoints - Plasma levels
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including:
- Peak concentration (Cmax)
Measured: From enrollment to Day 2 discharge
PK Endpoints - Plasma levels
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including:
- Terminal elimination rate constant (Kel) and half-life (T1/2)
Measured: From enrollment to Day 2 discharge
PK Endpoints - Plasma levels
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including:
- Area under the concentration-time curve (AUC)
Measured: From enrollment to Day 2 discharge
PK Endpoints - Plasma levels
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including:
- Apparent Oral Clearance (CL/F)
Measured: From enrollment to Day 2 discharge
PK Endpoints - Plasma levels
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including:
- Apparent Volume of distribution (V/F)
Measured: From enrollment to Day 2 discharge
Safety Endpoints - Clinically significant changes to physical exam
The incidence of adverse events related to changes to Complete Physical exam at screening and pre-dose. All other exams will be symptom-driven and performed at the very least on Day 2. Results will be reviewed for any abnormalities and clinical significance.
Measured: From informed consent/screening visit to Day 2
Safety Endpoints - Clinically significant changes to ECG results
The incidence of adverse related to Electrocardiography (ECG) results, measured by the change from baseline ECG parameters at screening, pre-dose and Day 2. The following parameters will be reviewed: heart rate, QT interval, PR interval, QRS interval, and QT corrected interval (QTcF [Fredericia's]).
All will be assessed as within normal limits, abnormal but not clinically significant, or abnormal and clinically significant on an ongoing basis. Comparison will be made by changes from baseline screening results.
Measured: From informed consent/screening visit to Day 2
Safety Endpoints - Clinically significant changes to clinical lab results
The incidence of adverse events based on the results of Clinical laboratory results, measured at screening, pre-dose and Day 2. Clinical labs to include chemistry, haematology, coagulation, and urinalysis. Results will be reviewed for any abnormalities and clinical significance.
Measured: From informed consent/screening visit to Day 2
Safety Endpoints - Clinically significant changes to vital signs
The incidence of adverse events based on the results of Vital signs, measured at screening, pre-dose and Day 2. This includes systolic/diastolic blood pressure (mmHg ), heart rate (beats per minute), temperature (◦C), and oxygen saturation (SpO2) via pulse oximetry). Results will be reviewed for any abnormalities and clinical significance.
Measured: From informed consent/screening visit to Day 2
Safety Endpoints - Changes to concomitant medications
Changes in baseline concomitant medications recorded from 14 days (or 5 half-lives, whichever is longer) prior to Screening through completion of the study.
Measured: From 14 days (or 5 half-lives, whichever is longer) prior to Screening through completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start29 Oct 2025
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- GEn1E Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InClin, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185113
- Sponsor's protocol ID
- GEn-1124-003
- Status last verified
- May 2026
- First submitted
- 11 Aug 2025
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Dose, Open-label Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07185113
- Acronym / sponsor ID
- GEn-1124-003
- Conditions
- Healthy Adult Male
- Keywords
- GEn-1124, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GEn1E LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- InClin, Inc.
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 22 Sep 2025 (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 goal of this clinical trial is to determine the pharmacokinetics (how the body interacts with administered substances for the entire duration of exposure) of Gen-1124 in an oral formulation (taken by mouth) in healthy volunteers. It will also learn about the safety of Gen-1124. The main questions it aims to answer are:
- How does Gen-1124 interact with a human body?
Researchers will look at how Gen-1124 interacts with the body and what side effects it may cause.
Participants will:
- Take Gen-1124 for a single dose
- Remain in clinic for 2 days for checkups and tests
- Recieve a phone call for a checkup 3 and 7 days after the single dose
Detailed description
Approximately 6 healthy male subjects who meet all eligibility criteria will be dosed.
There will be one single dose group of subjects dosed under fed (standardized meal) conditions.
Screening will be initiated up to 28 days before dosing. A follow-up visit will be completed approximately 7 days after dosing. Thus, total duration of subject participation in the study, excluding the Screening visit, will be approximately 8 days.
The incidence of adverse events from the time of informed consent through the final follow-up visit (end of study). This will be based on the results of:
- Physical exams,
- Electrocardiography (ECG) results,
- Clinical laboratory results,
- Vital signs,
- Concomitant medications. Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single oral dose in healthy male volunteers | Experimental | Drug: GEn-1124There will be only one group of participants that will receive a single oral capsule dose, administered under fed conditions following a standardized meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male subjects;
- Between 18 and 55 years of age;
- Provide a signed EC-approved consent form;
- Generally healthy, in the opinion of the Investigator;
- Body Mass Index (BMI) 18 to 32 kg/m^2;
Key exclusion criteria (11 listed)
- Subjects taking prohibited medication;
- Subjects with a history or presence of clinically significant medical or psychiatric disease;
- Subjects who have regularly used nicotine-containing products ;
- Subjects who have used caffeine-containing products;
- Subjects who are unable to comply with eating a standardized meal during the study;
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 |
|---|---|---|
| GEn-1124GEn-1124 will be administered to one single dose group of subjects dosed under fed (standardized meal) conditions. GEn-1124 will be administered as an oral capsule formulation containing GEn-1124. | Drug | Single oral dose in healthy male volunteers |
Primary outcome
PK Endpoints - Plasma levels
Time frame: From enrollment to Day 2 discharge
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including: • Peak concentration (Cmax)
PK Endpoints - Plasma levels
Time frame: From enrollment to Day 2 discharge
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including: • Terminal elimination rate constant (Kel) and half-life (T1/2)
PK Endpoints - Plasma levels
Time frame: From enrollment to Day 2 discharge
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including: • Area under the concentration-time curve (AUC)
PK Endpoints - Plasma levels
Time frame: From enrollment to Day 2 discharge
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including: • Apparent Oral Clearance (CL/F)
PK Endpoints - Plasma levels
Time frame: From enrollment to Day 2 discharge
Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including: • Apparent Volume of distribution (V/F)
Safety Endpoints - Clinically significant changes to physical exam
Time frame: From informed consent/screening visit to Day 2
The incidence of adverse events related to changes to Complete Physical exam at screening and pre-dose. All other exams will be symptom-driven and performed at the very least on Day 2. Results will be reviewed for any abnormalities and clinical significance.
Safety Endpoints - Clinically significant changes to ECG results
Time frame: From informed consent/screening visit to Day 2
The incidence of adverse related to Electrocardiography (ECG) results, measured by the change from baseline ECG parameters at screening, pre-dose and Day 2. The following parameters will be reviewed: heart rate, QT interval, PR interval, QRS interval, and QT corrected interval (QTcF [Fredericia's]). All will be assessed as within normal limits, abnormal but not clinically significant, or abnormal and clinically significant on an ongoing basis. Comparison will be made by changes from baseline screening results.
Safety Endpoints - Clinically significant changes to clinical lab results
Time frame: From informed consent/screening visit to Day 2
The incidence of adverse events based on the results of Clinical laboratory results, measured at screening, pre-dose and Day 2. Clinical labs to include chemistry, haematology, coagulation, and urinalysis. Results will be reviewed for any abnormalities and clinical significance.
Safety Endpoints - Clinically significant changes to vital signs
Time frame: From informed consent/screening visit to Day 2
The incidence of adverse events based on the results of Vital signs, measured at screening, pre-dose and Day 2. This includes systolic/diastolic blood pressure (mmHg ), heart rate (beats per minute), temperature (◦C), and oxygen saturation (SpO2) via pulse oximetry). Results will be reviewed for any abnormalities and clinical significance.
Safety Endpoints - Changes to concomitant medications
Time frame: From 14 days (or 5 half-lives, whichever is longer) prior to Screening through completion of the study.
Changes in baseline concomitant medications recorded from 14 days (or 5 half-lives, whichever is longer) prior to Screening through completion of the study.
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 May 2026.
- 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 GEn-1124 in people with Healthy Adult Male, run by GEn1E Lifesciences at 1 site in New Zealand.
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 8 inclusion and 11 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 May 2026. 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 New Zealand. 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?
PK Endpoints - Plasma levels (time frame: From enrollment to Day 2 discharge). The study lists 10 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 15 May 2026.