Health Trials

Phase 1/2 Study of KRRO-121 in Healthy Volunteers and Patients With UCD

ConditionsUrea Cycle Disorders, InbornUrea Cycle DisordersOrnithine Transcarbamylase (OTC) DeficiencyArginase 1 DeficiencyNAGS DeficiencyCarbamylphosphate Synthetase IOrnithine Transporter Mitochondrial 1Argininosuccinate SynthaseArgininosuccinate Lyase DeficiencyN-acetyl Glutamate - SynthetaseCitrin Deficiency
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKorro Bio, Inc.

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • KRRO-121
  • Placebo

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Korro Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov