A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects

NCT07185113 | Recruiting Phase 1

• 1 other identifier: GEn-1124-003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Healthy Adult Male

Keywords

GEn-1124; Healthy Volunteer

Outcome Measures

Primary Outcomes (10)

• PK Endpoints - Plasma levels

  Plasma levels of GEn-1124 and potential metabolites will be estimated using non-compartmental methods, including: • Peak concentration (Cmax)

  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)

  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)

  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)

  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)

  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.

  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.

  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.

  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.

  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.

  From 14 days (or 5 half-lives, whichever is longer) prior to Screening through completion of the study.

Study Arms (1)

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.

Drug: GEn-1124

Interventions

GEn-1124 DRUG

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.

Single oral dose in healthy male volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• InClin, Inc.: collaborator
• GEn1E Lifesciences: lead

Study Sites (1)

New Zealand Clinical Research (NZCR)

Christchurch, 8011, New Zealand

RECRUITING

Central Study Contacts

Ritu Lal, CEO, PhD, MS

CONTACT

650-248-2429; clinical@gen1elifesci.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 22, 2025
• Study Start: October 29, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)