HealthyPhase 1NCT06224400
A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult Subjects
A Phase 1 study testing ENC1018 for SAD and ENC1018 for MAD in people with Healthy, run by EnnovaBio Australia Pharmaceuticals Pty Ltd at 1 site in Australia.
Trial summary
This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and PK characteristics of ENC1018 after single and multiple oral dose administration in healthy adult subjects. 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?
- ENC1018 for SAD and ENC1018 for MAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Mar 2024to 15 Apr 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects of any ethnic origin, must be between 18 and 55 years of age inclusive.
- Subject is in generally good health according to the Investigator's assessment as determined by medical history, physical examination, vital sign assessment, 12-lead ECG, and clinical laboratory evaluations.
- Subject has a negative urine drug screen, cotinine screen, and alcohol breath test.
- Nonsmoker
- Subject has Body Mass Index 18.0 to 32.0 kg/m2 inclusive, and body weight from 50 - 100 kg for male subjects, 45 -100 kg for female subjects
- Apply contraception methods for child-bearing potential subjects.
Who cannot join
- Have clinically relevant medical history or unstable hepatic, pulmonary, hematologicalor immunological disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study, under the discretion of the Investigator.
- Any disease or surgical procedure (including cholecystectomy) that may substantially affect IP absorption, distribution, metabolism, and excretion 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.
- Dosing with any other investigational drug or therapy within 90 days prior to dosing.
- Is positive for HBsAg,HCVAb, HIVAb, or tuberculosis.
- Pregnant, breast-feeding and/or lactating women
- 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.
About this study
Official title: A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single and Multiple Doses of ENC1018 in Healthy Adult Subjects
This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and PK characteristics of ENC1018 after single and multiple oral dose administration in healthy adult subjects.
The study will be conducted in two parts: Part A -Single ascending Dose (SAD) and Part B - Multiple ascending dose (MAD). A Food Effect Cohort will be conducted within Part A. Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days.
Approximately 72 healthy adult subjects are planned to be enrolled. Each subject will be enrolled in only one cohort of either Parts A or B of the study, to receive only one dose regimen during the study. Part B may be initiated in parallel or prior to completion of Part A, at the discretion of Safety Review Committee (SRC), upon reviewing safety and plasma PK data.
- Conditions
- Healthy
- Being tested
- ENC1018 for SAD, Placebo for SAD, ENC1018 for MAD, Placebo for MAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENC1018 for SADDrug
SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort A1-A6) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally as a single dose.
Placebo for SADDrug
SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort A1-A6) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally as a single dose.
ENC1018 for MADDrug
MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort B1-B3) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally for a total of 14 days.
Placebo for MADDrug
MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort B1-B3) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally for a total of 14 days.
| Study group | Role | What they receive |
|---|---|---|
| ENC1018 for SAD | Experimental | 6 of out 8 subjects per cohort will be randomized to receive ENC1018 Receives: Drug: ENC1018 for SAD |
| Placebo for SAD | Placebo comparator | 2 of out 8 subjects per cohort will be randomized to receive placebo Receives: Drug: Placebo for SAD |
| ENC1018 for MAD | Experimental | 6 of out 8 subjects per cohort will be randomized to receive ENC1018 Receives: Drug: ENC1018 for MAD |
| Placebo for MAD | Placebo comparator | 2 of out 8 subjects per cohort will be randomized to receive placebo Receives: Drug: Placebo for MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of treatment emergent adverse events (TEAE) following ENC1018 administration will be assessed using the latest version of Medical Dictionary for Regulatory Activities (MedDRA 25.0 or above)
Measured: Day 1 through Day 8 (SAD) or 21 (MAD)
Severity of TEAEs following ENC1018 administration will be assessed using categories as mild, moderate and severe
Measured: Day 1 through Day 8 (SAD) or 21 (MAD)
Evaluations of clinical laboratory and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Laboratory values include hematology, biochemistry, clinical chemistry, coagulation, and urinalysis
Measured: Day 1 through Day 8 (SAD) or 21 (MAD)
Evaluations of physical examinations and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Physical examination include assessments of the skin, cardiovascular, respiratory, gastrointestinal, and neurological systems
Measured: Day 1 through Day 8 (SAD) or 21 (MAD)
Evaluations of vital signs and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Vital signs include body temperature, respiratory rate, blood pressure, and pulse
Measured: Day 1 through Day 8 (SAD) or 21 (MAD)
Evaluations of 12-lead ECGs and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
ECG parameters include heart rate, PR interval, QRS duration, QT interval, and QTcF interval
Measured: Day 1 through Day 8 (SAD) or 21 (MAD)
Secondary outcomes (6)
Maximum plasma concentration (Cmax)
Measured: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Area under the plasma concentration versus time curve (AUC)
Measured: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Time to maximum concentration (Tmax)
Measured: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Terminal elimination half-life (t1/2)
Measured: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Apparent oral plasma clearance (CL/F)
Measured: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Apparent volume of distribution during the terminal phase (Vz/F)
Measured: SAD: Up to Day 4, 72 hours post dose; MAD: 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.
- First posted25 Jan 2024
- Study start5 Mar 2024
- Primary completion9 Sep 2024
- Study completion15 Apr 2025
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- EnnovaBio Australia Pharmaceuticals Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Ryan, Doctor, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224400
- Sponsor's protocol ID
- ENC1018-P1-01
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2024
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single and Multiple Doses of ENC1018 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06224400
- Acronym / sponsor ID
- ENC1018-P1-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- EnnovaBio Australia Pharmaceuticals Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 25 Jan 2024 (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.
This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and PK characteristics of ENC1018 after single and multiple oral dose administration in healthy adult subjects.
The study will be conducted in two parts: Part A -Single ascending Dose (SAD) and Part B - Multiple ascending dose (MAD). A Food Effect Cohort will be conducted within Part A. Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days.
Approximately 72 healthy adult subjects are planned to be enrolled. Each subject will be enrolled in only one cohort of either Parts A or B of the study, to receive only one dose regimen during the study. Part B may be initiated in parallel or prior to completion of Part A, at the discretion of Safety Review Committee (SRC), upon reviewing safety and plasma PK data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ENC1018 for SAD | Experimental | Drug: ENC1018 for SAD6 of out 8 subjects per cohort will be randomized to receive ENC1018 |
| Placebo for SAD | Placebo comparator | Drug: Placebo for SAD2 of out 8 subjects per cohort will be randomized to receive placebo |
| ENC1018 for MAD | Experimental | Drug: ENC1018 for MAD6 of out 8 subjects per cohort will be randomized to receive ENC1018 |
| Placebo for MAD | Placebo comparator | Drug: Placebo for MAD2 of out 8 subjects per cohort will be randomized to receive placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female subjects of any ethnic origin, must be between 18 and 55 years of age inclusive.
- Subject is in generally good health according to the Investigator's assessment as determined by medical history, physical examination, vital sign assessment, 12-lead ECG, and clinical laboratory evaluations.
- Subject has a negative urine drug screen, cotinine screen, and alcohol breath test.
- Nonsmoker
- Subject has Body Mass Index 18.0 to 32.0 kg/m2 inclusive, and body weight from 50 - 100 kg for male subjects, 45 -100 kg for female subjects
Key exclusion criteria (7 listed)
- Have clinically relevant medical history or unstable hepatic, pulmonary, hematologicalor immunological disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study, under the discretion of the Investigator.
- Any disease or surgical procedure (including cholecystectomy) that may substantially affect IP absorption, distribution, metabolism, and excretion 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.
- Dosing with any other investigational drug or therapy within 90 days prior to dosing.
- Is positive for HBsAg,HCVAb, HIVAb, or tuberculosis.
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 |
|---|---|---|
| ENC1018 for SADSAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort A1-A6) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally as a single dose. | Drug | ENC1018 for SAD |
| Placebo for SADSAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort A1-A6) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally as a single dose. | Drug | Placebo for SAD |
| ENC1018 for MADMAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort B1-B3) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally for a total of 14 days. | Drug | ENC1018 for MAD |
| Placebo for MADMAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (cohort B1-B3) to receive either ENC1018 or placebo. The investigational product (ENC1018 or placebo) will be administered orally for a total of 14 days. | Drug | Placebo for MAD |
Primary outcome
Number and type of treatment emergent adverse events (TEAE) following ENC1018 administration will be assessed using the latest version of Medical Dictionary for Regulatory Activities (MedDRA 25.0 or above)
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)
Severity of TEAEs following ENC1018 administration will be assessed using categories as mild, moderate and severe
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)
Evaluations of clinical laboratory and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)
Laboratory values include hematology, biochemistry, clinical chemistry, coagulation, and urinalysis
Evaluations of physical examinations and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)
Physical examination include assessments of the skin, cardiovascular, respiratory, gastrointestinal, and neurological systems
Evaluations of vital signs and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)
Vital signs include body temperature, respiratory rate, blood pressure, and pulse
Evaluations of 12-lead ECGs and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)
ECG parameters include heart rate, PR interval, QRS duration, QT interval, and QTcF interval
6 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Area under the plasma concentration versus time curve (AUC)
Time frame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Time to maximum concentration (Tmax)
Time frame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Terminal elimination half-life (t1/2)
Time frame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Apparent oral plasma clearance (CL/F)
Time frame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: SAD: Up to Day 4, 72 hours post dose; MAD: 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 25 Apr 2025.
- 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.
Philip Ryan, Doctor principal investigator
Nucleus Network Pty Ltd.
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 ENC1018 for SAD and ENC1018 for MAD in people with Healthy, run by EnnovaBio Australia Pharmaceuticals Pty Ltd 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 6 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 25 Apr 2025. 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 and type of treatment emergent adverse events (TEAE) following ENC1018 administration will be assessed using the latest version of Medical Dictionary for Regulatory Activities (MedDRA 25.0 or above) (time frame: Day 1 through Day 8 (SAD) or 21 (MAD)). The study lists 6 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 25 Apr 2025.