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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06224400
• Other study ID #: ENC1018-P1-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 29, 2024
• Est. completion date: December 3, 2024

Study information

• Verified date: January 2024
• Source: EnnovaBio
• Contact: Philip Ryan, Doctor
• Phone: (03) 8593 9801
• Email: p.ryan[@]nucleusnetwork.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 3, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EnnovaBio Australia Pharmaceuticals Pty Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Day 1 through Day 8 (SAD) or 21 (MAD)
Primary	Severity of TEAEs following ENC1018 administration will be assessed using categories as mild, moderate and severe		Day 1 through Day 8 (SAD) or 21 (MAD)
Primary	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	Day 1 through Day 8 (SAD) or 21 (MAD)
Primary	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	Day 1 through Day 8 (SAD) or 21 (MAD)
Primary	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	Day 1 through Day 8 (SAD) or 21 (MAD)
Primary	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	Day 1 through Day 8 (SAD) or 21 (MAD)
Secondary	Maximum plasma concentration (Cmax)		SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary	Area under the plasma concentration versus time curve (AUC)		SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary	Time to maximum concentration (Tmax)		SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary	Terminal elimination half-life (t1/2)		SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary	Apparent oral plasma clearance (CL/F)		SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose
Secondary	Apparent volume of distribution during the terminal phase (Vz/F)		SAD: Up to Day 4, 72 hours post dose; MAD: up to Day 17, 72 hours post last dose