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Lo studio clinico NCT07408232 per Retinite Pigmentosa è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) Fase I, Fase II 50

In arruolamento
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La sperimentazione clinica NCT07408232 è uno studio interventistico di Fase I Fase II volto a esaminare il trattamento per Retinite Pigmentosa, attualmente in arruolamento. Avviato il 9 febbraio 2026, prevede di arruolare 50 partecipanti. Sotto la guida di Octant, Inc., dovrebbe concludersi entro il 1 novembre 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 13 febbraio 2026.
Sommario breve
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.
Descrizione dettagliata
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, to be conducted in Australia; and a Phase 1b/2, to be con...

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Titolo ufficiale

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of OCT-980 in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa

Patologie
Retinite Pigmentosa
Altri ID dello studio
  • OCT-980-101
Numero NCT
NCT07408232
Data di inizio (effettiva)
2026-02-09
Ultimo aggiornamento pubblicato
2026-02-13
Data di completamento (stimata)
2028-11-01
Arruolamento (previsto)
50
Tipo di studio
Interventistico
FASE
Fase I
Fase II
Stato
In arruolamento
Parole chiave
Rhodopsin-associated autosomal dominant Retinitis Pigmentosa
RHO-adRP
Retinitis Pigmentosa
Inherited Retinal Disease
autosomal dominant Retinitis Pigmentosa
Retinitis Pigmentosa 4
RP4
RP
Eye Diseases
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
Sequenziale
Mascheramento
Doppio
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentalePhase 1a: OCT-980
OCT-980 capsules administered orally once daily under fasted or fed conditions per protocol
Phase 1a: OCT-980 Capsule
OCT-980 capsules administered orally once at dose levels specified in the protocol
Comparatore placeboPhase 1a: Placebo
Matching placebo capsules administered orally once daily under fasted or fed conditions per protocol
Phase 1a: Placebo Capsule
Placebo capsules administered orally once at dose levels specified in the protocol
SperimentalePhase 1b/2: OCT-980
OCT-980 tablets administered orally once daily.
Phase 1b/2: OCT-980 Tablet
OCT-980 tablets administered orally once at dose levels specified in the protocol
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Safety and tolerability of single (Phase 1a) or multiple doses (Phase 1b/2) of OCT-980 in volunteers or participants with a genetic diagnosis of RHO-adRP, respectively
Time Frame: From Baseline to Day 5 (Phase 1a) or Week 60 (Ph 1b/2)
Assistente alla partecipazione
Criteri di eleggibilità

Inclusion

Phase 1a (Single Ascending Dose Escalation in Healthy Volunteers) Inclusion:

  • Be in good general health, as determined by the Investigator
  • Male or female age 18 to 65 years (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
  • Have sufficient venous access to allow blood sampling for pharmacokinetic analysis and safety laboratory samples
  • Participants in Cohort 2b will be asked to participate in an additional food effect cohort and capable of consuming the high-fat meal within the protocol-specified time period and willing to consume 100% of the high-fat meal

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 age 18 to 65 years (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) > 70
  • 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 Exclusion

Phase 1a (Single Ascending Dose Escalation in Healthy Volunteers) Exclusion:

  • Females who are pregnant or breastfeeding
  • Have evidence of any significant ocular or non-ocular disease/ disorder
  • Has lifetime history of ocular surgery
  • 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

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
Octant, Inc. logoOctant, Inc.
Contatti principali dello studio
Contatto: Octant adRP Clinical Operations, +1-510-500-5956, [email protected]
1 Centri dello studio in 1 paesi

South Australia

CMAX Clinical Research Pty Ltd, Adelaide, South Australia, 5000, Australia
Thomas Polasek Polasek, MD, Contatto, 61870887900, [email protected]
Jane Kelly, Contatto, 61870887900, [email protected]
In arruolamento