MedTrace Logo

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

NCT06294288 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-12

No results posted yet for this study

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

Interventions

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.

BIOLOGICAL

LP-003 Dose 3 (Single)

A single dose of LP-003 (Dose 3) was administered intravenously.

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.

Sponsors & Collaborators

  • Longbio Pharma

    lead INDUSTRY

Principal Investigators

  • Xueying Ding · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2024-03-04
Completion
2024-03-04

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06294288 on ClinicalTrials.gov