NCT07347223

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DD-S052P in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: HLB Science · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This Phase 1 study is a randomized, double-blind, placebo-controlled, first-in-human clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of DD-S052P following intravenous administration in healthy adult subjects. The study consists of two sequential parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. In the SAD part, cohorts of healthy subjects will receive a single intravenous infusion of DD-S052P or placebo at escalating dose levels. Dose escalation to the next cohort will occur only after a review of available safety and tolerability data from the preceding cohort, in accordance with predefined stopping and escalation criteria. In the MAD part, healthy subjects will receive multiple intravenous doses of DD-S052P or placebo administered once daily over consecutive days. Dose levels for the MAD part will be selected based on the safety, tolerability, and pharmacokinetic results obtained from the SAD part. Safety and tolerability will be evaluated throughout the study by monitoring adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination findings, electrocardiograms (ECGs), and clinical laboratory parameters. Pharmacokinetic assessments will be conducted to characterize plasma concentration-time profiles of DD-S052P following single and multiple dosing. Key pharmacokinetic parameters will be derived using standard non-compartmental methods, as appropriate. The results of this study will provide essential information on the safety profile and pharmacokinetic characteristics of DD-S052P and will support further clinical development.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-24
• Primary completion: 2025-05-23
• Completion: 2025-05-23
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study