NCT06294275

A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects

A Phase I Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of LP-001 Injection in Healthy Subjects Following Single and Multiple Doses

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Longbio Pharma · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-001 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-001 and Part 2, multiple ascending dose (MAD).

Conditions

• Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
BIOLOGICAL	LP-001 Dose 1 (Single)	A single dose of LP-001 (Dose 1) was administered subcutaneously.
BIOLOGICAL	LP-001 Dose 2 (Single)	A single dose of LP-001 (Dose 2) was administered subcutaneously.
BIOLOGICAL	LP-001 Dose 3 (Single)	A single dose of LP-001 (Dose 3) was administered subcutaneously.
BIOLOGICAL	LP-001 Dose 4 (Single)	A single dose of LP-001 (Dose 4) was administered subcutaneously.
BIOLOGICAL	LP-001 Dose 5 (Single)	A single dose of LP-001 (Dose 5) was administered subcutaneously.
BIOLOGICAL	LP-001 Dose 6 (Single)	A single dose of LP-001 (Dose 6) was administered subcutaneously.
BIOLOGICAL	Placebo (Single)	A single dose of placebo was administered subcutaneously.
BIOLOGICAL	LP-001 Dose 7 (Multiple)	LP-001 (Dose 7) was administered multiple times subcutaneously.
BIOLOGICAL	LP-001 Dose 8 (Multiple)	LP-001 (Dose 8) was administered multiple times subcutaneously.
BIOLOGICAL	Placebo (Multiple)	Placebo was administered multiple times subcutaneously.

Timeline

• Start date: 2022-09-03
• Primary completion: 2023-08-16
• Completion: 2023-08-16
• First posted: 2024-03-05
• Last updated: 2025-12-15

Locations

1 site across 1 country: China