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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06224400




Registration number
NCT06224400
Ethics application status
Date submitted
8/01/2024
Date registered
25/01/2024

Titles & IDs
Public title
A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult Subjects
Scientific 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
Secondary ID [1] 0 0
ENC1018-P1-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ENC1018 for SAD
Treatment: Drugs - Placebo for SAD
Treatment: Drugs - ENC1018 for MAD
Treatment: Drugs - Placebo for MAD

Experimental: ENC1018 for SAD - 6 of out 8 subjects per cohort will be randomized to receive ENC1018

Placebo comparator: Placebo for SAD - 2 of out 8 subjects per cohort will be randomized to receive placebo

Experimental: ENC1018 for MAD - 6 of out 8 subjects per cohort will be randomized to receive ENC1018

Placebo comparator: Placebo for MAD - 2 of out 8 subjects per cohort will be randomized to receive placebo


Treatment: Drugs: ENC1018 for SAD
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.

Treatment: Drugs: Placebo for SAD
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.

Treatment: Drugs: ENC1018 for MAD
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.

Treatment: Drugs: Placebo for MAD
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Day 1 through Day 8 (SAD) or 21 (MAD)
Primary outcome [2] 0 0
Severity of TEAEs following ENC1018 administration will be assessed using categories as mild, moderate and severe
Timepoint [2] 0 0
Day 1 through Day 8 (SAD) or 21 (MAD)
Primary outcome [3] 0 0
Evaluations of clinical laboratory and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Timepoint [3] 0 0
Day 1 through Day 8 (SAD) or 21 (MAD)
Primary outcome [4] 0 0
Evaluations of physical examinations and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Timepoint [4] 0 0
Day 1 through Day 8 (SAD) or 21 (MAD)
Primary outcome [5] 0 0
Evaluations of vital signs and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Timepoint [5] 0 0
Day 1 through Day 8 (SAD) or 21 (MAD)
Primary outcome [6] 0 0
Evaluations of 12-lead ECGs and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
Timepoint [6] 0 0
Day 1 through Day 8 (SAD) or 21 (MAD)
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary outcome [2] 0 0
Area under the plasma concentration versus time curve (AUC)
Timepoint [2] 0 0
SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary outcome [3] 0 0
Time to maximum concentration (Tmax)
Timepoint [3] 0 0
SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary outcome [4] 0 0
Terminal elimination half-life (t1/2)
Timepoint [4] 0 0
SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary outcome [5] 0 0
Apparent oral plasma clearance (CL/F)
Timepoint [5] 0 0
SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary outcome [6] 0 0
Apparent volume of distribution during the terminal phase (Vz/F)
Timepoint [6] 0 0
SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/04/2025
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EnnovaBio Australia Pharmaceuticals Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Ryan, Doctor
Address 0 0
Nucleus Network Pty Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06224400