๐ฌIn plain words
What the trial is, and whether it could suit you
Phase 1/2 Study of KRRO-121 is a randomized, placebo-controlled study in Healthy Volunteers (Phase 1 SAD and MAD) and Study Participants with Urea Cycle Disorders (Phase 2). The primary objective of the study is to evaluate the safety of KRRO-121.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Adult male or female participants, 18 to 65 years of age
* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and screening laboratory assessments, in the opinion of the Investigator.
* Female participant of childbearing potential or male participant that is willing to use an approved, reliable means of contraception
* Willing and able to provide signed written informed consent and to comply with all study requirements
Exclusion Criteria:
* Any medical history that is clinically significant in the opinion of the Principal Investigator and Sponsor Medical Monitor
* Any laboratory value at screening or predose on Day -1 outside the local laboratory reference range that is clinically significant in the opinion of the Principal Investigator and Sponsor Medical Monitor
* Evidence of active systemic infection at Screening or Day 1 requiring antimicrobial, antiviral, or antifungal therapy
* Use of any investigational drug or device within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Concurrent participation in any other interventional clinical study
Nucleus Network Pty Ltd
Melbourne, Australia
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.