MedTrace Logo

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

NCT06294275 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-12-15

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-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

BIOLOGICAL

Placebo (Multiple)

Placebo was administered multiple times subcutaneously.

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.

Sponsors & Collaborators

  • Longbio Pharma

    lead INDUSTRY

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
2022-09-03
Primary Completion
2023-08-16
Completion
2023-08-16

Countries

  • China

Study Locations

More Related Trials

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 NCT06294275 on ClinicalTrials.gov