Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124

A Phase 1a/1b, Randomized, Double-blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124 After Single and Multiple IV Infusion Dosing in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04728061

Enrollment

Registered

2021-01-28

Start date

2021-01-07

Completion date

2021-06-18

Last updated

2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

In this early phase clinical research study, the investigational drug will be administered to 64 healthy volunteers in a double-blind, placebo-controlled manner, at a one research center. The objectives of the study are to assess what the body does to the investigational drug, what the investigational drug does to the body and also to observe the safety and tolerability of the investigational drug healthy volunteers.

Interventions

DRUGGen1E-1124

Intravenously-infused Gen1E-1124 in vehicle.

DRUGPlacebo

Intravenously-infused vehicle.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male and female subjects; 2. Between 18 and 55 years of age; 3. Provide a signed EC-approved consent form; 4. Generally healthy, in the opinion of the Investigator; 5. Body Mass Index (BMI) 18 to 30 kg/m\^2; 6. Creatinine clearance with in specific parameter; 7. Using method of contraception; 8. Willing and able to comply with protocol requirements for the duration of the study.

Exclusion criteria

1. Subjects taking prohibited medication; 2. Subjects with a history or presence of clinically significant medical or psychiatric disease; 3. Subjects who have regularly used nicotine-containing products ; 4. Subjects who have used caffeine-containing products; 5. Subjects who are unable to comply with eating a standardized meal during the study; 6. Subjects with a hospital admission or major surgery within 30 days prior to Screening; 7. Subjects with a plasma donation within 7 days prior to Screening; 8. 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; 9. Subjects who cannot refrain from strenuous exercise from 72 hours prior to dose administration through completion of the Follow-up Visit; 10. Subjects who are pregnant or breastfeeding 11. Subjects who have participated (taken investigative drug and/or device) in another clinical trial within 90 days prior to Screening; 12. 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.

Design outcomes

Primary

Measure	Time frame
The incidence of adverse events from the start of randomization through the final follow-up visit	Up to 14 days post-dose

Secondary

Measure	Time frame
Plasma levels of GEn1E-1124 and potential metabolites	Through 24 hours post-dose
Urine levels of GEn1E-1124 and potential metabolites	Through 24 hours post-dose
Cytokines measured in whole blood	Up to 24 hours post-dose
Selected biomarkers measured in whole blood	Up to 24 hours post-dose

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026