- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05506540
A First-in-human Single Ascending Dose/Multiple Ascending Dose Study of ENN0403 in Healthy Subjects
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Adelaide, Australia
- CMAX Clinical Research Pty Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single Ascending Dose, ENN0403 1 mg
Single oral use of ENN0403 at dose level 1 mg, in fasted state.
|
ENN0403 capsules for oral use
|
EXPERIMENTAL: Single Ascending Dose, ENN0403 4 mg
Single oral use of ENN0403 at dose level 4 mg, in fasted state.
|
ENN0403 capsules for oral use
|
EXPERIMENTAL: Single Ascending Dose, ENN0403 10 mg
Single oral use of ENN0403 at dose level 10 mg, in fasted state.
|
ENN0403 capsules for oral use
|
EXPERIMENTAL: Single Ascending Dose, ENN0403 20 mg
Single oral use of ENN0403 at dose level 20 mg, in fasted state.
|
ENN0403 capsules for oral use
|
EXPERIMENTAL: Single Ascending Dose, ENN0403 30 mg
Single oral use of ENN0403 at dose level 30 mg, in fasted state.
|
ENN0403 capsules for oral use
|
EXPERIMENTAL: Single Ascending Dose, ENN0403 20 mg (Fed)
Single oral use of ENN0403 at dose level 30 mg, after high calorie and high-fat breakfast meal.
|
ENN0403 capsules for oral use
|
EXPERIMENTAL: Multiple Ascending Dose, ENN0403 6 mg
ENN0403 capsules for oral administration, 6 mg QD X 14 Days
|
ENN0403 capsules for oral use
|
EXPERIMENTAL: Multiple Ascending Dose, ENN0403 12 mg
ENN0403 capsules for oral administration, 12 mg QD X 14 Days
|
ENN0403 capsules for oral use
|
EXPERIMENTAL: Multiple Ascending Dose, ENN0403 20 mg
ENN0403 capsules for oral administration, 20 mg QD X 14 Days
|
ENN0403 capsules for oral use
|
PLACEBO_COMPARATOR: Single/Multiple Ascending Dose, placebo capsules for oral adminstration
Placebo capsules for oral administration
|
Placebo capsules for oral use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
From first dose of ENN0403 administration till 7 days after last dose of ENN0403 administration.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Cmax is the maximum measured concentration of ENN0403 in plasma after oral administration
|
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
|
AUC is the area under the concentration-time curve of ENN0403 in plasma after oral administration
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ENN0403-P1-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on ENN0403 1mg
-
University of EdinburghNHS LothianCompleted
-
Chong Kun Dang PharmaceuticalCompleted
-
Boryung Pharmaceutical Co., LtdCompletedSmoking CessationKorea, Republic of
-
Woman'sNovo Nordisk A/SRecruitingPre Diabetes | Postpartum DisorderUnited States
-
Abalonex, LLCNot yet recruitingTraumatic Brain Injury | Cerebral Edema
-
Rigel PharmaceuticalsCompletedAsthmaUnited States, Canada
-
Korea University Anam HospitalCompletedHealthyKorea, Republic of
-
Shanghai Pharmaceuticals Holding Co., LtdCompletedChronic Abnormal Immune Activation in HIV/AIDSChina
-
Philip Morris Products S.A.CompletedPharmacokineticsRussian Federation
-
Johns Hopkins UniversityCultivate BiologicsCompleted