A Phase 1/2 interventional study of Phase 1b/2: Cohort 1 - OCT-980 Tablet and Phase 1b/2: Cohort 2 - OCT-980 Tablet in Retinitis Pigmentosa, sponsored by Octant, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Octant, Inc. · Phase 1/2, Interventional, and Treatment
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.
Octant, Inc. is evaluating OCT-980, an oral small molecule corrector for the treatment of patients with rhodopsin (RHO)-associated autosomal dominant retinitis pigmentosa (RHO-adRP). There is no known cure and no currently approved therapy for RHO-adRP, a disease of the retina characterized by progressive loss of vision.
This study is comprised of a Phase 1a in healthy volunteers, which was conducted in Australia and is now complete.
The phase 1b/2 study is an open-label, multi-center multiple ascending dose escalation (MAD) to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of multiple-ascending doses of OCT-980 for up to 48 weeks, in participants with a genetic diagnosis of Rhodopsin-associated, autosomal dominant Retinitis Pigmentosa (RP).
RHO-adRP participants are currently being recruited for the phase 1b/2 study in the US.
Phase 1b/2 is active. Inclusion
Phase 1b/2 (Multiple Ascending Dose Escalation in RHO-adRP Patients) Inclusion:
Phase 1b/2 (Multiple Ascending Dose Escalation in RHO-adRP Patients) Exclusion:
OCT-980 tablets administered orally once daily.
Drug: Phase 1b/2: Cohort 1 - OCT-980 Tablet
OCT-980 tablets administered orally once daily.
Drug: Phase 1b/2: Cohort 2 - OCT-980 Tablet
OCT-980 tablets administered orally once daily.
Drug: Phase 1b/2: Cohort 3 - OCT-980 Tablet
OCT-980 tablets administered orally once daily.
Drug: Phase 1b/2: Cohort 4 - OCT-980 Tablet
OCT-980 tablets administered orally once daily.
Drug: Phase 1b/2: Cohort 5 - OCT-980 Tablet
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
Safety and tolerability of multiple doses (Phase 1b/2) of OCT-980 in participants with a genetic diagnosis of RHO-adRP.
Time frame: Time Frame: From Baseline to Week 60 (Ph 1b/2)
Plan to share: Undecided
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