A Phase 1/2a, Single- and Multiple-dose Escalation Study of KRRO-110 (NCT06677307) | Clinical Trial Compass
TerminatedPhase 1/2
A Phase 1/2a, Single- and Multiple-dose Escalation Study of KRRO-110
Stopped: The study was terminated for business decision reasons.
Australia, New Zealand42 participantsStarted 2025-01-13
Plain-language summary
The purpose of this first-in human (FIH) study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple doses of KRRO-110 in both healthy adult participants and in clinically stable patients with Alpha-1 antitrypsin deficiency (AATD).
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Part A SAD cohort Inclusion Criteria (Healthy Volunteers)
* Adult male or female participants, 18 to 65 years of age
* Documented PiMM genotype
* Participants who are willing to and able to provide signed written informed consent
PiZZ Genotype (Part A SAD and Part B MAD cohorts) Inclusion Criteria (PiZZ Genotype)
* Adult male or female participants 18 to 70 years of age (inclusive)
* Documented PiZZ genotype
* Baseline blood total AAT level \< 11 µM/L
Exclusion Criteria:
Exclusion Criteria (Healthy Volunteers)
* Female participant of childbearing potential or male participant that is unable or unwilling to use an approved, reliable means of contraception
* Body mass index (BMI) \> 32 or \< 18.5 kg/m2
* History or current clinical evidence of hepatic disease
* Evidence of active infection
* History of medical condition(s), eg, advance cardiac disease, current or recent malignancy, organ transplantation, or other illness
* Serology result indicative of any exposure (past or active) to hepatitis C, hepatitis B, or human immunodeficiency virus (HIV)
* Respiratory or other acute illness within 8 weeks
* Tobacco use of any kind within 6 months
Exclusion Criteria (PiZZ Genotype)
* Female participant of childbearing potential or male participant that is unable or unwilling to use an approved, reliable means of contraception
* BMI \> 32 or \< 18.5 kg/m2 or weight \> 90 kg
* History of FEV1 \< 35%
* History or current clinical evidence of advanced hepatic d…
What they're measuring
1
Safety and Tolerability
Timeframe: From Day 1 to Day 43 in the SAD and from Day 1 to Day 85 in the MAD