Actively Recruiting
A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
Led by Octant, Inc. · Updated on 2026-02-13
50
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This integrated Ph1/2 clinical study is to assess the safety, tolerability and pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of OCT-980 in healthy volunteers and participants with RHO-adRP.
CONDITIONS
Official Title
A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be in good general health
- Male or female age 18 to 65 years at time of consent
- Body weight over 50 kg with BMI between 18.0 and 35.0 at screening
- Sufficient venous access for blood sampling
- For cohort 2b in Phase 1a, able and willing to consume a high-fat meal as required
- Diagnosis of rhodopsin-associated autosomal dominant retinitis pigmentosa confirmed by genetic test
- Best corrected visual acuity greater than 70 on ETDRS scale
- Good general health aside from RHO-adRP as determined by investigator
You will not qualify if you...
- Pregnant or breastfeeding females
- Evidence of significant ocular or non-ocular disease or disorder (other than RHO-adRP in Phase 1b/2)
- History of ocular surgery
- History of major surgery, severe trauma, or bone fracture within 12 weeks before first dose or planned surgery within 4 weeks after study end
- Any prior or current ophthalmologic gene therapy in Phase 1b/2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
O
Octant adRP Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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