Safety, Tolerability, and Pharmacokinetics of DD-S052P in Healthy Volunteers

NCT07347223 | Completed Phase 1 FDA Drug

• 1 other identifier: DD-S052P-P1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study designed to evaluate the safety, tolerability, and pharmacokinetics of DD-S052P in healthy adult volunteers. The study consists of two parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. In the SAD part, participants will receive a single intravenous infusion of DD-S052P or placebo at increasing dose levels. In the MAD part, participants will receive multiple intravenous infusions of DD-S052P or placebo over several days. Safety and tolerability will be assessed through monitoring of adverse events, vital signs, physical examinations, electrocardiograms (ECGs), and clinical laboratory tests. Pharmacokinetic assessments will be performed to characterize plasma concentrations of DD-S052P over time following single and multiple dosing. The results of this study will provide important information to support further clinical development of DD-S052P.

Conditions

Healthy Volunteer

Keywords

DD-S052P; Phase 1; First-in-Human; Healthy Volunteers; Single Ascending Dose; Intravenous Administration; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Safety and tolerability will be evaluated by summarizing the number of participants experiencing one or more treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following administration of DD-S052P. Adverse events will be assessed by the Investigator for severity and relationship to study drug. Severity grading will follow CTCAE v5.0, where applicable.

  From first study drug administration through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).

• Change From Baseline in Vital Signs

  Change from baseline will be assessed for the following vital sign parameters: systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (beats per minute), oral body temperature (°C), oxygen saturation (SpO₂, %), and respiratory rate (breaths per minute).

  From baseline (pre-dose) through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).

• Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters

  Change from baseline will be assessed for the following 12-lead ECG parameters: QT interval corrected using Fridericia's formula (QTcF, ms), PR interval (ms), and QRS duration (ms).

  From baseline (pre-dose) through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).

• Number of Participants With Clinically Significant Abnormal Laboratory Results

  Clinically significant abnormal laboratory findings will be summarized as the number of participants with one or more abnormal laboratory results, as assessed by the Investigator. Laboratory assessments include hematology, serum chemistry/biochemistry, coagulation parameters, thyroid function tests, and urinalysis.

  From baseline through the end-of-study visit (approximately up to Day 8 for Part A [SAD] and up to Day 14 for Part B [MAD]).

Study Arms (2)

DD-S052P (SAD/MAD)

EXPERIMENTAL

Participants receive DD-S052P administered as an intravenous infusion over 4 hours. Single ascending doses (SAD) or multiple ascending doses (MAD) are evaluated to assess safety, tolerability, and pharmacokinetics in healthy volunteers.

Drug: DD-S052P

Placebo (SAD/MAD)

PLACEBO COMPARATOR

Participants receive placebo (Ringer solution) administered as an intravenous infusion over 4 hours, matching the dosing schedule of the DD-S052P treatment in the single and multiple ascending dose cohorts.

Drug: Placebo

Interventions

Placebo DRUG

Placebo solution administered as an intravenous infusion, matching the investigational product in appearance, volume, and administration schedule.

Placebo (SAD/MAD)

DD-S052P DRUG

DD-S052P is administered as an intravenous infusion at single or multiple ascending dose levels to evaluate safety, tolerability, and pharmacokinetics in healthy adult subjects.

DD-S052P (SAD/MAD)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male/female aged to 18-50 years inclusive at the screening visit
• Must agree to adhere to the contraception requirements:
• Female must be of non-childbearing potential, defined as meeting at least one of the following:
• hysteroscopic sterilization
• bilateral tubal ligation or bilateral salpingectomy
• hysterectomy
• bilateral oophorectomy
• be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
• Female of childbearing potential who are sexually active must agree to use at least one highly effective method of contraception starting from the 1 month prior to first administration of the study drug until 4 months post-dosing:
• Hormonal methods: oral, transdermal, systemic, or implantable contraceptives
• Intrauterine devices (IUDs)
• Barrier methods: condoms or diaphragms used with spermicide
• Surgical sterilization of the male partner
• Male must use of condom by the male subject plus an effective method of contraception for the subject partner of childbearing potential from study drug administration until 4 months post-dosing (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm, surgical sterilization, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle)
• Male subjects must not donate sperm from the first dosing until 90 days after the last dosing

You may not qualify if:

• Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, infectious disease; endocrine, immunologic, dermatologic or/and any relevant disease
• Subject with proteinuria, Grade 2 or higher (CTCAE, Ver.5.0)
• Symptomatic hypotension whatever the decrease of the blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within 2 min of changing from supine to standing position
• Positive urine drug testing or alcohol testing at Screening or Day -1
• Positive Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
• Clinical symptoms suspected of acute infectious disease within 2 weeks before the first study drug administration
• Any medication intake (except acetaminophen) within 1 month or within 5 times the elimination half-life of the medication (whichever is longer) prior to the first administration of study drug
• Serious or severe adverse reaction, including hypersensitivity, anaphylaxis or hepatotoxicity to carbapenems, cephalosporins, penicillins, polyethylene glycol derivatives, monobactams or any other medication
• History of hypersensitivity to Ringer solution
• Blood donation (including as part of a clinical trial) within 2 months before administration
• General anaesthesia within 3 months before administration
• Inability to abstain from intense muscular effort
• Subjects who cannot be reliably contacted in case of an emergency
• Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses/day)
• Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development

Sponsors & Collaborators

• HLB Science: lead

Study Sites (1)

HLB Science

Seoul, Seoul, 05836, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Participants, investigators, care providers, and outcome assessors are blinded to treatment assignment. Study drug and placebo are identical in appearance and administered in a blinded manner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to receive either DD-S052P or placebo in parallel cohorts within single ascending dose and multiple ascending dose parts.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 16, 2026
• Study Start: July 24, 2023
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-12

Locations

KR (1)