MedTrace Logo

Safety of Single and Repeat Dose of PYC-001 Eye Injections in People With Autosomal Dominant Optic Atrophy (Myrtle)

NCT06970106 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-08

No results posted yet for this study

Summary

This study aims to gather safety data and determine the optimal dosing regimen for PYC-001 in participants with confirmed OPA1 mutation-associated ADOA. Approximately 18 participants from Australia, New Zealand, and other APAC countries are expected to be enrolled, depending on safety review committee (SRC) throughout the course of the study.

Participants may be assigned to any of the following:

1. A single 60ug dose of PYC-001
2. Three doses of 10ug PYC-001 at an interval of 8 weeks
3. Three doses of 10ug PYC-001 at an interval of 12 weeks
4. Three doses of 30ug PYC-001 at an interval of 8 weeks
5. Three doses of 30ug PYC-001 at an interval of 12 weeks

Following completion of the 4 week safety review of the single 60ug of PYC-001 cohort, and if the 60 μg dose level is deemed safe by the SRC, the following cohorts will also be available:
6. Three doses of 60ug PYC-001 at an interval of 12 weeks

Conditions

Interventions

DRUG

PYC-001

PYC-001 is a peptide-phosphorodiamidate morpholino oligonucleotide administered intravitreally

Sponsors & Collaborators

  • PYC Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-12-01
Completion
2028-01-01

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970106 on ClinicalTrials.gov