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.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 18 is below the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →This is the only study on the registry with Octant, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Nov 2028, 31 months after the start.
Of 28 phase 1/2 interventional studies under Retinitis Pigmentosa, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 92. This study's planned 31 months is below that.
How these figures are worked out, and which studies are left out of them.
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