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A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
RecruitingPhase 1/2
A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of OCT-980 in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- Phase 1b/2: Cohort 1 - OCT-980 Tablet (drug)
- Phase 1b/2: Cohort 2 - OCT-980 Tablet (drug)
- Phase 1b/2: Cohort 3 - OCT-980 Tablet (drug)
- Phase 1b/2: Cohort 4 - OCT-980 Tablet (drug)
- Phase 1b/2: Cohort 5 - OCT-980 Tablet (drug)
Sponsor: Octant, Inc. · Participants: 18 · Started: Mar 10, 2026
Contact the study team
- Octant adRP Clinical Operations · Phone: +1-510-500-5956
Official record on ClinicalTrials.gov — NCT07408232
Locations in the U.S.
| Oregon | Casey Eye Institute, Portland |
| Texas | Retina Foundation of the Southwest, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.