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Recruiting
NCT07408232
A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
Conditions: Retinitis Pigmentosa
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 18
Sponsor: Octant, Inc.
Location: Casey Eye Institute Portland Oregon
Summary
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.
Eligibility Criteria
Phase 1b/2 is active. Inclusion
Phase 1b/2 (Multiple Ascending Dose Escalation in RHO-adRP Patients) Inclusion:
* Participants must have a diagnosis of Rhodopsin-associated, autosomal dominant Retinitis Pigmentosa confirmed by a genetic test that is implemented in accordance with the relevant national requirements
* Male or female greater than or equal to age 18 (inclusive) at the time of signing the informed consent form
* Have a body weight \>50kg, with a body mass index (BMI) from 18.0 to 35.0 kg/m\^2 (inclusive) at screening
* Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) \> 55
* Other than their diagnosis of RHO-adRP, be in good general health, as determined by the Investigator
* Have sufficient venous access to allow blood sampling for pharmacokinetic analysis and safety laboratory samples
Phase 1b/2 (Multiple Ascending Dose Escalation in RHO-adRP Patients) Exclusion:
* Females who are pregnant or breastfeeding
* Evidence of any other significant ocular (other than RHO-adRP) and non-ocular disease/ disorder
* Lifetime history of ocular surgery
* Any prior or current ophthalmologic gene therapy
* Has a history of major surgery, severe trauma, or bone fracture within 12 weeks before the first dose of the investigational product or planned surgery within 4 weeks after the end of the study
Source: ClinicalTrials.gov (NCT07408232). StuddyBuddy aggregates publicly available trial information.