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Safety, Tolerability, PK, PD and Preliminary Efficacy of ONO-4685

NCT05332704 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-08-21

No results posted yet for this study

Summary

This is an early phase study to assess the safety and tolerability of ONO-4685 in patients with psoriasis. In addition, the study will assess how the drug is distributed and eliminated by the body (pharmacokinetics) and how the drug affects the body (pharmacodynamics). This will be done by measuring the amount of drug in the blood and measuring other markers in the body that might have been affected by ONO-4685. The study will also look at preliminary information on whether ONO-4685 might be effective in treating psoriasis.

The study will be split into three parts. Part A will assess a single dose of ONO-4685 in small groups of patients, each group planned to receive a higher dose than the last group. In Part B and C, patients will receive multiple doses of ONO-4685 over a period of 4 weeks.

Conditions

Interventions

DRUG

ONO-4685

-Part A: Single ascending doses of ONO-4685 as a single IV dose (Cohort A1-A5).

DRUG

Placebo

-Part A: Single ascending doses of placebo as a single IV dose (Cohort A1-A5).

DRUG

ONO-4685

-Part B: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort B1 and B2)

DRUG

Placebo

-Part B: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort B1 and B2).

DRUG

ONO-4685

-Part C: Multiple doses of ONO-4685 as IV doses over a 4-week treatment period (Cohort C1 and C2).

DRUG

Placebo

-Part C: Multiple doses of placebo as IV doses over a 4-week treatment period (Cohort C1 and C2).

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2024-07-18
Completion
2024-07-18

Countries

  • Moldova
  • Romania
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05332704 on ClinicalTrials.gov