A First-in-Human SAD/MAD Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC1018 in Healthy Adult Subjects

NCT ID: NCT06224400

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2025-04-15

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ENC1018 for SAD

6 of out 8 subjects per cohort will be randomized to receive ENC1018

Group Type: EXPERIMENTAL

ENC1018 for SAD

Intervention Type: DRUG

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 SAD

2 of out 8 subjects per cohort will be randomized to receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo for SAD

Intervention Type: DRUG

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 MAD

6 of out 8 subjects per cohort will be randomized to receive ENC1018

Group Type: EXPERIMENTAL

ENC1018 for MAD

Intervention Type: DRUG

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 MAD

2 of out 8 subjects per cohort will be randomized to receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo for MAD

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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 Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EnnovaBio Australia Pharmaceuticals Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Ryan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network Pty Ltd.

Locations

Nucleus Network Pty Ltd.

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

ENC1018-P1-01

Identifier Type: -

Identifier Source: org_study_id