HealthyPhase 1NCT05506540

A First-in-human Single Ascending Dose/Multiple Ascending Dose Study of ENN0403 in Healthy Subjects

A Phase 1 study testing ENN0403 1mg, ENN0403 4mg and ENN0403 10mg in people with Healthy, run by EnnovaBio at 1 site in Australia.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ENN0403 1mg, ENN0403 4mg and ENN0403 10mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 69 participants
Where: 1 siteAustralia
Study dates: 17 Feb 2021to 16 May 2022
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

Capable of giving signed informed consent.
18 to 55 years old (inclusive).
BMI of 18 to 30 kg/m2 (inclusive); body weight >50 to <100 kg for male subjects or >45 to <100 kg for female subjects.
Computerized (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the PI.
Test negative for COVID-19.
Test negative for HBsAg, anti-HBc, anti-hepatitis C virus (HCV) antibodies, anti-human immuno deficiencyvirus (HIV) 1 and 2 antibodies, and tuberculosis.

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Have a negative urine drug screen and a negative alcohol breath test.
Nonsmoker or occasional smoker and willingness to refrain from smoking during study.
Ability and willingness to abstain from alcohol during study.
not pregnant, not breastfeeding; apply contraception methods for child-bearing potential subjects.

Who cannot join

History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal,cardiovascular, hepatic, psychiatric, neurologic, or allergic disease in the opinion of the Investigator within 12 months prior to Screening.
Any disease or take any medication that affects IP absorption, distribution, metabolism, and excretion.3. Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval.
Presence of malignancy including hematological malignancies. Subjects with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 3 years of Screening will be allowed for inclusion, as judged by the Investigator.
Any current active infections, including localized infections, or any recent history (within 1 week prior to IP administration) of active infections, cough or fever; or a history of recurrent or chronic infections.
In the 12-lead ECG assessment, QTcF >450 ms for male subjects or >470 ms for female subjects.7. Estimated glomerular fltration rate <90 mL /min (using the Cockcroft-Gault formula) at Screening.
ALT or aspartate aminotransferase>1.5ULN.
Have received any live vaccines (bacterial or viral) within 12 weeks prior to Screening or intend to receive a live vaccine during the study period or within 30 days after the last dose of the IP.

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX Clinical Research Pty Ltd
Adelaide, Adelaide

Other trials in Australia

About this study

Official title: A Phase 1, First-in-human, 2-part, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENN0403 in Healthy Adult Subjects

This is a FIH, randomized, double- blind, placebo-controlled, dose -escalation study to investigate the safety, tolerability, PK, and PD of ENN0403 after single and multiple oral dose administration in healthy adult subjects. The study will include 2 parts which will proceed in a parallel staggered manner: Part A, a single ascending dose (SAD) study and Part B, a multiple ascending dose (MAD) study.

Approximately 80 healthy adult subjects will be enrolled at a single site in Australia, in up to 6 cohorts in Part A (SAD study), including a Food Effect (FE) study, and up to 4 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days. Each cohort will include 8 subjects (6 receiving ENN0403 and 2 receiving placebo). Each subject will be enrolled in only 1 cohort and receive only one dose regimen in this study.

Dosing will be escalated in a sequential fashion, contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). The proposed dose levels/ dosing frequency of ENN0403 may be adjusted over the course of the whole study and cohorts may be added or removed depending on the emerging safety, tolerability, and available PK data.

Conditions: Healthy
Being tested: ENN0403 1mg, ENN0403 4mg, ENN0403 10mg, ENN0403 20mg, ENN0403 30mg

What participants receive

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

ENN0403 1mgDrug
ENN0403 capsules for oral use
ENN0403 4mgDrug
ENN0403 capsules for oral use
ENN0403 10mgDrug
ENN0403 capsules for oral use
ENN0403 20mgDrug
ENN0403 capsules for oral use
ENN0403 30mgDrug
ENN0403 capsules for oral use
ENN0403 20mg (Fed)Drug
ENN0403 capsules for oral use
ENN0403 6mg QD X 14 DaysDrug
ENN0403 capsules for oral use
ENN0403 12mg QD X 14 DaysDrug
ENN0403 capsules for oral use
ENN0403 20mg QD X 14 DaysDrug
ENN0403 capsules for oral use
PlaceboDrug
Placebo capsules for oral use

Study groups in NCT05506540
Study group	Role	What they receive
Single Ascending Dose, ENN0403 1 mg	Experimental	Single oral use of ENN0403 at dose level 1 mg, in fasted state. Receives: Drug: ENN0403 1mg
Single Ascending Dose, ENN0403 4 mg	Experimental	Single oral use of ENN0403 at dose level 4 mg, in fasted state. Receives: Drug: ENN0403 4mg
Single Ascending Dose, ENN0403 10 mg	Experimental	Single oral use of ENN0403 at dose level 10 mg, in fasted state. Receives: Drug: ENN0403 10mg
Single Ascending Dose, ENN0403 20 mg	Experimental	Single oral use of ENN0403 at dose level 20 mg, in fasted state. Receives: Drug: ENN0403 20mg
Single Ascending Dose, ENN0403 30 mg	Experimental	Single oral use of ENN0403 at dose level 30 mg, in fasted state. Receives: Drug: ENN0403 30mg
Single Ascending Dose, ENN0403 20 mg (Fed)	Experimental	Single oral use of ENN0403 at dose level 30 mg, after high calorie and high-fat breakfast meal. Receives: Drug: ENN0403 20mg (Fed)
Multiple Ascending Dose, ENN0403 6 mg	Experimental	ENN0403 capsules for oral administration, 6 mg QD X 14 Days Receives: Drug: ENN0403 6mg QD X 14 Days
Multiple Ascending Dose, ENN0403 12 mg	Experimental	ENN0403 capsules for oral administration, 12 mg QD X 14 Days Receives: Drug: ENN0403 12mg QD X 14 Days
Multiple Ascending Dose, ENN0403 20 mg	Experimental	ENN0403 capsules for oral administration, 20 mg QD X 14 Days Receives: Drug: ENN0403 20mg QD X 14 Days
Single/Multiple Ascending Dose, placebo capsules for oral adminstration	Placebo comparator	Placebo capsules for oral administration Receives: Drug: Placebo

What is being measured

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

Number of participants with treatment emergent adverse events (TEAE) following ENN0403 administration
Measured: From first dose of ENN0403 administration till 7 days after last dose of ENN0403 administration.

Secondary outcomes (2)

Maximum Plasma Concentration [Cmax]
Cmax is the maximum measured concentration of ENN0403 in plasma after oral administration
Measured: Single Ascending Dose (SAD) part: up to Day 4, 72 hours post dose; Multiple Ascending Dose (MAD) part: up to Day 17, 72 hours post last dose
Area Under the Curve [AUC]
AUC is the area under the concentration-time curve of ENN0403 in plasma after oral administration
Measured: Single Ascending Dose (SAD) part: up to Day 4, 72 hours post dose; Multiple Ascending Dose (MAD) part: up to Day 17, 72 hours post last dose

Timeline

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

17 Feb 202116 May 2022

First posted18 Aug 2022
Study start17 Feb 2021
Primary completion16 May 2022
Study completion16 May 2022

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: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05506540
Sponsor's protocol ID: ENN0403-P1-01
Status last verified: Sep 2024
First submitted: 9 Aug 2022
Last updated: 19 Sep 2024
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?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, First-in-human, 2-part, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENN0403 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT05506540
Acronym / sponsor ID: ENN0403-P1-01
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: EnnovaBioIndustry (pharma, biotech, devices)
Study start: 17 Feb 2021 (actual)
Primary completion: 16 May 2022 (actual)
Study completion: 16 May 2022 (actual)
First posted: 18 Aug 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Single Ascending Dose, ENN0403 1 mg	Experimental	Drug: ENN0403 1mgSingle oral use of ENN0403 at dose level 1 mg, in fasted state.
Single Ascending Dose, ENN0403 4 mg	Experimental	Drug: ENN0403 4mgSingle oral use of ENN0403 at dose level 4 mg, in fasted state.
Single Ascending Dose, ENN0403 10 mg	Experimental	Drug: ENN0403 10mgSingle oral use of ENN0403 at dose level 10 mg, in fasted state.
Single Ascending Dose, ENN0403 20 mg	Experimental	Drug: ENN0403 20mgSingle oral use of ENN0403 at dose level 20 mg, in fasted state.
Single Ascending Dose, ENN0403 30 mg	Experimental	Drug: ENN0403 30mgSingle oral use of ENN0403 at dose level 30 mg, in fasted state.
Single Ascending Dose, ENN0403 20 mg (Fed)	Experimental	Drug: ENN0403 20mg (Fed)Single oral use of ENN0403 at dose level 30 mg, after high calorie and high-fat breakfast meal.
Multiple Ascending Dose, ENN0403 6 mg	Experimental	Drug: ENN0403 6mg QD X 14 DaysENN0403 capsules for oral administration, 6 mg QD X 14 Days
Multiple Ascending Dose, ENN0403 12 mg	Experimental	Drug: ENN0403 12mg QD X 14 DaysENN0403 capsules for oral administration, 12 mg QD X 14 Days
Multiple Ascending Dose, ENN0403 20 mg	Experimental	Drug: ENN0403 20mg QD X 14 DaysENN0403 capsules for oral administration, 20 mg QD X 14 Days
Single/Multiple Ascending Dose, placebo capsules for oral adminstration	Placebo comparator	Drug: PlaceboPlacebo capsules for oral administration

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Capable of giving signed informed consent.
18 to 55 years old (inclusive).
BMI of 18 to 30 kg/m2 (inclusive); body weight >50 to <100 kg for male subjects or >45 to <100 kg for female subjects.
Computerized (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the PI.
Test negative for COVID-19.

Key exclusion criteria (7 listed)

History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal,cardiovascular, hepatic, psychiatric, neurologic, or allergic disease in the opinion of the Investigator within 12 months prior to Screening.
Any disease or take any medication that affects IP absorption, distribution, metabolism, and excretion.3. Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval.
Presence of malignancy including hematological malignancies. Subjects with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 3 years of Screening will be allowed for inclusion, as judged by the Investigator.
Any current active infections, including localized infections, or any recent history (within 1 week prior to IP administration) of active infections, cough or fever; or a history of recurrent or chronic infections.
In the 12-lead ECG assessment, QTcF >450 ms for male subjects or >470 ms for female subjects.7. Estimated glomerular fltration rate <90 mL /min (using the Cockcroft-Gault formula) at Screening.

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
ENN0403 1mgENN0403 capsules for oral use	Drug	Single Ascending Dose, ENN0403 1 mg
ENN0403 4mgENN0403 capsules for oral use	Drug	Single Ascending Dose, ENN0403 4 mg
ENN0403 10mgENN0403 capsules for oral use	Drug	Single Ascending Dose, ENN0403 10 mg
ENN0403 20mgENN0403 capsules for oral use	Drug	Single Ascending Dose, ENN0403 20 mg
ENN0403 30mgENN0403 capsules for oral use	Drug	Single Ascending Dose, ENN0403 30 mg
ENN0403 20mg (Fed)ENN0403 capsules for oral use	Drug	Single Ascending Dose, ENN0403 20 mg (Fed)
ENN0403 6mg QD X 14 DaysENN0403 capsules for oral use	Drug	Multiple Ascending Dose, ENN0403 6 mg
ENN0403 12mg QD X 14 DaysENN0403 capsules for oral use	Drug	Multiple Ascending Dose, ENN0403 12 mg
ENN0403 20mg QD X 14 DaysENN0403 capsules for oral use	Drug	Multiple Ascending Dose, ENN0403 20 mg
PlaceboPlacebo capsules for oral use	Drug	Single/Multiple Ascending Dose, placebo capsules for oral adminstration

Primary outcome

Number of participants with treatment emergent adverse events (TEAE) following ENN0403 administration
Time frame: From first dose of ENN0403 administration till 7 days after last dose of ENN0403 administration.

2 secondary outcomes

Maximum Plasma Concentration [Cmax]
Time frame: Single Ascending Dose (SAD) part: up to Day 4, 72 hours post dose; Multiple Ascending Dose (MAD) part: up to Day 17, 72 hours post last dose
Area Under the Curve [AUC]
Time frame: Single Ascending Dose (SAD) part: up to Day 4, 72 hours post dose; Multiple Ascending Dose (MAD) part: up to Day 17, 72 hours post last 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 19 Sep 2024.
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 ENN0403 1mg, ENN0403 4mg and ENN0403 10mg in people with Healthy, run by EnnovaBio at 1 site in Australia.

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 10 inclusion and 7 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 19 Sep 2024. 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 Australia. 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. Some participants in this study may receive a placebo. 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?

Number of participants with treatment emergent adverse events (TEAE) following ENN0403 administration (time frame: From first dose of ENN0403 administration till 7 days after last dose of ENN0403 administration.). 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 NCT05506540.

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 19 Sep 2024.