HealthyPhase 1NCT04728061
Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124
A Phase 1 study testing Gen1E-1124 in people with Healthy, run by GEn1E Lifesciences at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gen1E-1124
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteNew Zealand
- Study dates
- 7 Jan 2021to 18 Jun 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female 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 30 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 are pregnant or breastfeeding
- 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 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
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.
- Conditions
- Healthy
- Being tested
- Gen1E-1124, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gen1E-1124Drug
Intravenously-infused Gen1E-1124 in vehicle.
PlaceboDrug
Intravenously-infused vehicle.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Not described Receives: Drug: Gen1E-1124; Drug: Placebo |
| Multiple Ascending Dose | Experimental | Not described Receives: Drug: Gen1E-1124; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events from the start of randomization through the final follow-up visit
Measured: Up to 14 days post-dose
Secondary outcomes (4)
Plasma levels of GEn1E-1124 and potential metabolites
Measured: Through 24 hours post-dose
Urine levels of GEn1E-1124 and potential metabolites
Measured: Through 24 hours post-dose
Cytokines measured in whole blood
Measured: Up to 24 hours post-dose
Selected biomarkers measured in whole blood
Measured: Up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start7 Jan 2021
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- GEn1E Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ritu Lal, PhD, MS, Study director, GEn1E Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728061
- Sponsor's protocol ID
- GEn1E-1124-001
- Status last verified
- Nov 2021
- First submitted
- 22 Jan 2021
- Last updated
- 2 Dec 2021
- Results posted
- 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 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04728061
- Acronym / sponsor ID
- GEn1E-1124-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GEn1E LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 28 Jan 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: Gen1E-1124, Drug: Placebo |
| Multiple Ascending Dose | Experimental | Drug: Gen1E-1124, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male and female 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 30 kg/m^2;
Key exclusion criteria (12 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 |
|---|---|---|
| Gen1E-1124Intravenously-infused Gen1E-1124 in vehicle. | Drug | Multiple Ascending Dose, Single Ascending Dose |
| PlaceboIntravenously-infused vehicle. | Drug | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
The incidence of adverse events from the start of randomization through the final follow-up visit
Time frame: Up to 14 days post-dose
4 secondary outcomes
Plasma levels of GEn1E-1124 and potential metabolites
Time frame: Through 24 hours post-dose
Urine levels of GEn1E-1124 and potential metabolites
Time frame: Through 24 hours post-dose
Cytokines measured in whole blood
Time frame: Up to 24 hours post-dose
Selected biomarkers measured in whole blood
Time frame: Up to 24 hours post-dose
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 2 Dec 2021.
- Sponsor WebsiteLink provided by the sponsor.
- 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.
Ritu Lal, PhD, MS study director
GEn1E Lifesciences
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 Gen1E-1124 in people with Healthy, 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 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 2 Dec 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 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?
The incidence of adverse events from the start of randomization through the final follow-up visit (time frame: Up to 14 days post-dose). 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 2 Dec 2021.