A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
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
Octant, Inc.
50 participants
Feb 9, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- Be in good general health, as determined by the Investigator
- Male or female age 18 to 65 years (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
- Have sufficient venous access to allow blood sampling for pharmacokinetic analysis and safety laboratory samples
- Participants in Cohort 2b will be asked to participate in an additional food effect cohort and capable of consuming the high-fat meal within the protocol-specified time period and willing to consume 100% of the high-fat meal
- 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 age 18 to 65 years (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) > 70
- 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 Exclusion
Exclusion Criteria9
- Females who are pregnant or breastfeeding
- Have evidence of any significant ocular or non-ocular disease/ disorder
- Has lifetime history of ocular surgery
- 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
- 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
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Interventions
OCT-980 capsules administered orally once at dose levels specified in the protocol
Placebo capsules administered orally once at dose levels specified in the protocol
OCT-980 tablets administered orally once at dose levels specified in the protocol
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07408232