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Not Yet Recruiting
NCT07773246
Phase 1/2 Study of KRRO-121 in Healthy Volunteers and Patients With UCD
Conditions: Urea Cycle Disorders, Inborn, Urea Cycle Disorders, Ornithine Transcarbamylase (OTC) Deficiency, Arginase 1 Deficiency, NAGS Deficiency, Carbamylphosphate Synthetase I, Ornithine Transporter Mitochondrial 1, Argininosuccinate Synthase, Argininosuccinate Lyase Deficiency, N-acetyl Glutamate - Synthetase, Citrin Deficiency
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: Korro Bio, Inc.
Location: Nucleus Network Pty Ltd Melbourne Victoria
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07773246). StuddyBuddy aggregates publicly available trial information.