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

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Autoimmune Diseases

Treatments: Drug: DWP212525 100mg; Drug: DWP212525 400mg; Drug: DWP212525 placebo; Drug: DWP212525 30mg; Drug: DWP212525 50mg; Drug: DWP212525 10mg; Drug: DWP212525 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06736587

DW_DWP212525101

Details and patient eligibility

About

The safety and tolerability of single and multiple administration of DWP212525

Full description

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

Enrollment: 76 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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76 participants in 10 patient groups

Cohort2

Experimental group

Description:

SAD

Treatment:

Drug: DWP212525 placebo

Drug: DWP212525 30mg

Cohort3

Experimental group

Description:

SAD

Treatment:

Drug: DWP212525 50mg

Drug: DWP212525 placebo

Cohort4

Experimental group

Description:

SAD

Treatment:

Drug: DWP212525 placebo

Drug: DWP212525 100mg

Cohort5

Experimental group

Description:

SAD

Treatment:

Drug: DWP212525 200mg

Drug: DWP212525 placebo

Cohort6

Experimental group

Description:

SAD

Treatment:

Drug: DWP212525 placebo

Drug: DWP212525 400mg

Cohort7

Experimental group

Description:

MAD

Treatment:

Drug: DWP212525 placebo

Drug: DWP212525 30mg

Cohort8

Experimental group

Description:

MAD

Treatment:

Drug: DWP212525 50mg

Drug: DWP212525 placebo

Cohort9

Experimental group

Description:

MAD

Treatment:

Drug: DWP212525 placebo

Drug: DWP212525 100mg

Cohort10

Experimental group

Description:

MAD

Treatment:

Drug: DWP212525 200mg

Drug: DWP212525 placebo

Cohort1

Experimental group

Description:

SAD

Treatment:

Drug: DWP212525 10mg

Drug: DWP212525 placebo