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A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Tiral in Healthy Male Volunteers

NCT ID: NCT06736587

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2026-06-30

Brief Summary

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The safety and tolerability of single and multiple administration of DWP212525

Detailed Description

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The safety and tolerability of single and multiple administration of DWP212525 will be evaluated in healthy adult male volunteers.

Conditions

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Autoimmune Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort2

SAD

Group Type EXPERIMENTAL

DWP212525 30mg

Intervention Type DRUG

DWP212525 30mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort3

SAD

Group Type EXPERIMENTAL

DWP212525 50mg

Intervention Type DRUG

DWP212525 50mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort4

SAD

Group Type EXPERIMENTAL

DWP212525 100mg

Intervention Type DRUG

DWP212525 100mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort5

SAD

Group Type EXPERIMENTAL

DWP212525 200mg

Intervention Type DRUG

DWP212525 200mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort6

SAD

Group Type EXPERIMENTAL

DWP212525 400mg

Intervention Type DRUG

DWP212525 400mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort7

MAD

Group Type EXPERIMENTAL

DWP212525 30mg

Intervention Type DRUG

DWP212525 30mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort8

MAD

Group Type EXPERIMENTAL

DWP212525 50mg

Intervention Type DRUG

DWP212525 50mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort9

MAD

Group Type EXPERIMENTAL

DWP212525 100mg

Intervention Type DRUG

DWP212525 100mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort10

MAD

Group Type EXPERIMENTAL

DWP212525 200mg

Intervention Type DRUG

DWP212525 200mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Cohort1

SAD

Group Type EXPERIMENTAL

DWP212525 10mg

Intervention Type DRUG

DWP212525 10mg

DWP212525 placebo

Intervention Type DRUG

DWP212525 placebo

Interventions

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DWP212525 10mg

DWP212525 10mg

Intervention Type DRUG

DWP212525 30mg

DWP212525 30mg

Intervention Type DRUG

DWP212525 50mg

DWP212525 50mg

Intervention Type DRUG

DWP212525 100mg

DWP212525 100mg

Intervention Type DRUG

DWP212525 200mg

DWP212525 200mg

Intervention Type DRUG

DWP212525 400mg

DWP212525 400mg

Intervention Type DRUG

DWP212525 placebo

DWP212525 placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy adult male volunteers aged 19 to 55 years, Caucasian
2. Those with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 30.0 kg/m2
3. Received a sufficient explanation on this study
4. Eligible as subjects in the study

Exclusion Criteria

1. History of diseases such as clinically significant disease of hepatobiliary
2. Following conditions applicable to clinically significant acute or chronic infections or the past history confirmed via an interview
3. Hemato-oncologic diseases, including malignant tumor diagnosis
4. Past history of tuberculosis infection or confirmed tuberculosis in the IGRA test and chest X-ray test
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Seunghwan Lee

Role: primary

Other Identifiers

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DW_DWP212525101

Identifier Type: -

Identifier Source: org_study_id