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

ConditionRetinitis Pigmentosa

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorOctant, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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/m² (inclusive) at screening

Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) > 55

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

Phase 1b/2: Cohort 1 - OCT-980 Tablet
Drug
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
Phase 1b/2: Cohort 2 - OCT-980 Tablet
Drug
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
Phase 1b/2: Cohort 3 - OCT-980 Tablet
Drug
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
Phase 1b/2: Cohort 4 - OCT-980 Tablet
Drug
OCT-980 tablets administered orally once daily at dose levels specified in the protocol
Phase 1b/2: Cohort 5 - OCT-980 Tablet
Drug
OCT-980 tablets administered orally once daily at dose levels specified in the protocol

Treatment groups

18 Participants

are divided into 5 treatment groups

Group A: Phase 1b/2: OCT-980 Cohort 1Experimental treatment 1 intervention

Group B: Phase 1b/2: OCT-980 Cohort 2Experimental treatment 1 intervention

Group C: Phase 1b/2: OCT-980 Cohort 3Experimental treatment 1 intervention

Group D: Phase 1b/2: OCT-980 Cohort 4Experimental treatment 1 intervention

Group E: Phase 1b/2: OCT-980 Cohort 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Octant, Inc.

Lead sponsor

Source ClinicalTrials.gov

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