Recruiting

Phase 1

Phase 2

OCT-980A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)

Sponsor:

Octant, Inc.

Code:

NCT07408232

Conditions

Retinitis Pigmentosa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Phase 1b/2: Cohort 1 - OCT-980 Tablet

Phase 1b/2: Cohort 2 - OCT-980 Tablet

Phase 1b/2: Cohort 3 - OCT-980 Tablet

Phase 1b/2: Cohort 4 - OCT-980 Tablet

Phase 1b/2: Cohort 5 - OCT-980 Tablet

Study Details

Brief 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.

Conditions

Retinitis Pigmentosa

Study ID

NCT07408232

Start date

Mar 10, 2026

Status verified date

Sep, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1b/2: OCT-980 Cohort 1

OCT-980 tablets administered orally once daily.

experimental: Phase 1b/2: OCT-980 Cohort 2

OCT-980 tablets administered orally once daily.

experimental: Phase 1b/2: OCT-980 Cohort 3

OCT-980 tablets administered orally once daily.

experimental: Phase 1b/2: OCT-980 Cohort 4

OCT-980 tablets administered orally once daily.

experimental: Phase 1b/2: OCT-980 Cohort 5

OCT-980 tablets administered orally once daily.

Interventions

Phase 1b/2: Cohort 1 - OCT-980 Tablet