NCT06294288

A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-003 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (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-003 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-003 and Part 2, multiple ascending dose (MAD).

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
BIOLOGICAL	LP-003 Dose 1 (Single)	A single dose of LP-003 (Dose 1) was administered intravenously.
BIOLOGICAL	LP-003 Dose 2 (Single)	A single dose of LP-003 (Dose 2) was administered intravenously.
BIOLOGICAL	LP-003 Dose 3 (Single)	A single dose of LP-003 (Dose 3) was administered intravenously.
BIOLOGICAL	LP-003 Dose 4 (Single)	A single dose of LP-003 (Dose 4) was administered intravenously.
BIOLOGICAL	LP-003 Dose 5 (Single)	A single dose of LP-003 (Dose 5) was administered intravenously.
BIOLOGICAL	Placebo (Single)	A single dose of placebo was administered intravenously.
BIOLOGICAL	LP-003 Dose 6 (Multiple)	LP-003 (Dose 6) was administered multiple times subcutaneously.
BIOLOGICAL	LP-003 Dose 7 (Multiple)	LP-003 (Dose 7) was administered multiple times subcutaneously.
BIOLOGICAL	LP-003 Dose 8 (Multiple)	LP-003 (Dose 8) was administered multiple times subcutaneously.
BIOLOGICAL	Placebo (Multiple)	Placebo was administered multiple times subcutaneously.

Timeline

• Start date: 2022-07-13
• Primary completion: 2024-03-04
• Completion: 2024-03-04
• First posted: 2024-03-05
• Last updated: 2025-12-12

Locations

1 site across 1 country: China