Trials / Completed
CompletedNCT05332834
A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects
A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SM17 When Administered Intravenously as a Single Ascending Dose in Healthy Subjects (Part A) and as Multiple Ascending Doses in Healthy Subjects (Part B)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- SinoMab BioScience Ltd · Industry
- Sex
- All
- Age
- 19 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This trial is a phase 1, first-in-human, randomized, double-blind, placebo-controlled dose escalation trial following single and multiple doses intravenous administration of SM17. It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single and multiple doses of SM17 injection in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SM17 | Peripheral intravenous injection |
| OTHER | Placebo | Peripheral intravenous injection |
Timeline
- Start date
- 2022-06-14
- Primary completion
- 2023-09-26
- Completion
- 2023-09-26
- First posted
- 2022-04-18
- Last updated
- 2024-09-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05332834. Inclusion in this directory is not an endorsement.