A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants
NCT06294301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2025-12-15
Summary
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 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-005 and Part 2, multiple ascending dose (MAD).
Conditions
- Paroxysmal Nocturnal Hemoglobinuria (PNH)
Interventions
- BIOLOGICAL
-
LP-005 Dose 7 (Multiple)
LP-005 (Dose 7) was administered multiple times intravenously.
- BIOLOGICAL
-
LP-005 Dose 8 (Multiple)
LP-005 (Dose 8) was administered multiple times intravenously.
- BIOLOGICAL
-
LP-005 Dose 9 (Multiple)
LP-005 (Dose 9) was administered multiple times intravenously.
- BIOLOGICAL
-
Placebo (Multiple)
Placebo was administered multiple times intravenously.
- BIOLOGICAL
-
LP-005 Dose 1 (Single)
A single dose of LP-005 (Dose 1) was administered intravenously.
- BIOLOGICAL
-
LP-005 Dose 2 (Single)
A single dose of LP-005 (Dose 2) was administered intravenously.
- BIOLOGICAL
-
LP-005 Dose 3 (Single)
A single dose of LP-005 (Dose 3) was administered intravenously.
- BIOLOGICAL
-
LP-005 Dose 4 (Single)
A single dose of LP-005 (Dose 4) was administered intravenously.
- BIOLOGICAL
-
LP-005 Dose 5 (Single)
A single dose of LP-005 (Dose 5) was administered intravenously.
- BIOLOGICAL
-
LP-005 Dose 6 (Single)
A single dose of LP-005 (Dose 6) was administered intravenously.
- BIOLOGICAL
-
Placebo (Single)
A single dose of placebo was administered intravenously.
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
- 2023-11-23
- Primary Completion
- 2024-08-31
- Completion
- 2024-08-31
Countries
- China
Study Locations
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