Trials / Completed
CompletedNCT06294301
A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of LP-005 in Healthy Volunteers
- 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-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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2023-11-23
- Primary completion
- 2024-08-31
- Completion
- 2024-08-31
- First posted
- 2024-03-05
- Last updated
- 2025-12-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06294301. Inclusion in this directory is not an endorsement.