A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421-T1 and DW4421S-T1 in Healthy Adult Volunteers

Daewon Pharmaceutical

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy Adult Volunteer

Treatments: Drug: DW4421-T1; Drug: DW4421S-T1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07364851

DW4421-105

Details and patient eligibility

About

Safety and pharmacokinetic characteristics evaluation of DW4421-T1 and DW4421S-T1

Enrollment: 38 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult aged 19 to 50 (inclusive) years
• Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive)

Exclusion criteria

• clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Sequence A

Experimental group

Description:

cross-over

Treatment:

Drug: DW4421S-T1

Drug: DW4421-T1

Sequence B

Experimental group

Description:

Cross-over

Treatment:

Drug: DW4421S-T1

Drug: DW4421-T1