Clinical trial NCT06224400: A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: EnnovaBio
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: 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.

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.

Primary outcomes:
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)
timeFrame: Day 1 through Day 8 (SAD) or 21 (MAD)
measure: Severity of TEAEs following ENC1018 administration will be assessed using categories as mild, moderate and severe
timeFrame: Day 1 through Day 8 (SAD) or 21 (MAD)
measure: Evaluations of clinical laboratory and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
timeFrame: Day 1 through Day 8 (SAD) or 21 (MAD)
measure: Evaluations of physical examinations and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
timeFrame: Day 1 through Day 8 (SAD) or 21 (MAD)
measure: Evaluations of vital signs and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
timeFrame: Day 1 through Day 8 (SAD) or 21 (MAD)
measure: Evaluations of 12-lead ECGs and changes from baseline will be assessed using descriptive statistics following ENC1018 administration
timeFrame: Day 1 through Day 8 (SAD) or 21 (MAD)
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
measure: Time to maximum concentration (Tmax)
timeFrame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
measure: Terminal elimination half-life (t1/2)
timeFrame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
measure: Apparent oral plasma clearance (CL/F)
timeFrame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
measure: Apparent volume of distribution during the terminal phase (Vz/F)
timeFrame: SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd.
state: Victoria
Study officials:
affiliation: Nucleus Network Pty Ltd.
name: Philip Ryan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: