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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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
Retina Foundation of the Southwest
Dallas, Texas, United States
RECRUITINGSafety 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)
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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