Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: DWP14012 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06508645

DW_DWJ1521102

Details and patient eligibility

About

A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers

Enrollment: 33 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults aged ≥ 19 and ≤ 50 years at screening

2. Subjects with a body weight of ≥ 55.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 and ≤ 28.0 at screening

   ☞ BMI(kg/m2) = weight (kg) / {Height (m)}2

3. Subjects who have given written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study

4. Subjects eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, investigator questioning, etc.

Exclusion criteria

1. Present or prior history of clinically significant hepatic, renal, nervous system, immune, respiratory, and endocrine diseases, hematologic and oncologic diseases, cardiovascular diseases, or mental diseases
2. Gastrointestinal diseases (gastric ulcer, gastritis, gastric cramps, gastroesophageal reflux, Crohn's disease, etc.) that may affect the safety and pharmacokinetic evaluation results of investigational drugs and those with a history of gastrointestinal surgery (except for appendix surgery and hernia surgery alone).
3. Helicobacter pylori positive.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 4 patient groups, including a placebo group

Part1 Treatment Group_1

Placebo Comparator group

Description:

Part1 Treatment Group_1_low dose DWP14012 injection Amg, Multiple administration, 7 days Placebo: Normal saline

Treatment:

Drug: DWP14012 injection

Part1 Treatment Group_2

Placebo Comparator group

Description:

Part1 Treatment Group_2_medium dose DWP14012 injection Bmg, Multiple administration, 7 days Placebo: Normal saline

Treatment:

Drug: DWP14012 injection

Part1 Treatment Group_3

Placebo Comparator group

Description:

Part1 Treatment Group_3_high dose DWP14012 injection Cmg, Multiple administration, 7 days Placebo: Normal saline

Treatment:

Drug: DWP14012 injection

Part2 Treatment Group

Experimental group

Description:

Part2 Treatment Group_continuous intravenous administration - DWP14012 injection Dmg, Loading dose / DWP14012 injection Emg for 3 days, Maintenance dose

Treatment:

Drug: DWP14012 injection