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

NCT07347223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-01-16

No results posted yet for this study

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

Interventions

DRUG

DD-S052P

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • HLB Science

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2025-05-23
Completion
2025-05-23
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347223 on ClinicalTrials.gov