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drugset / Trial / NCT06045624

A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects

NCT06045624 ↗

Phase 1 Withdrawn Ornovi, Inc.
RandomizedSequentialQuadruple-blindTreatment

Summary

This first in human phase 1 study to Study will evaluate safety, tolerability, and pharmacokinetics of Single Ascending dose (SAD), Food effect (FE) and Multiple ascending dose (MAD) of OR-101 Administered Orally in healthy subjects

Timeline

Start
2023-10-17
Primary completion
2024-02-06
Completion
2024-02-06

Outcome

Outcome not reported

Stopped: “The study was cancelled as the sponsor decided to reformulate the IP”

Drugs

EvaluationDrugModalityDoseRoute
Subject OR-101 Unknown 15 mg Oral
Subject OR-101 Unknown 45 mg Oral
Subject OR-101 Unknown 135 mg Oral
Subject OR-101 Unknown 150 mg Oral
Subject OR-101 Unknown 270 mg Oral
Subject OR-101 Unknown 450 mg Oral
Subject OR-101 Unknown 540 mg Oral
Subject OR-101 Unknown 900 mg Oral
Subject OR-101 Unknown 1500 mg Oral

Indications

alopecia areata