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

Launched by ENNOVABIO AUSTRALIA PHARMACEUTICALS PTY LTD · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to test a new medication called ENC1018 in healthy adults. Researchers want to learn how safe the drug is, how well it is tolerated, and how it behaves in the body after taking it in single and multiple doses. The study has two parts: one where participants will take a single dose, and another where they will take the medication once a day for 14 days. In total, around 72 healthy adults aged between 18 and 55 will be involved, and they will only participate in one part of the study.

To be eligible to join the trial, participants must be in good health, not smoke, and have a body weight within a specific range. They also need to pass some health checks and tests, like having a normal urine drug test. People with certain medical conditions or who are pregnant or breastfeeding cannot participate. If someone joins the study, they will receive either the new medication or a placebo (a harmless pill that looks the same but has no active ingredients) without knowing which one they got. This helps researchers determine the drug's effects more accurately. Overall, the trial aims to gather important information to help understand if ENC1018 could be a safe and effective treatment option in the future.

Gender

ALL

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.