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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07773246). StuddyBuddy aggregates publicly available trial information.