Trials / Completed
CompletedNCT03795142
A First-time-in-human Study of BGB149
A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BGB149 Following Single Dose Administration in Healthy Subjects
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- BerGenBio ASA · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This clinical trial is a Phase I, first-in-human. The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of BGB149 after single IV doses in healthy male and female subjects. Multiple dose levels will be explored.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BGB149 | Single Ascending Dose |
| BIOLOGICAL | Placebo | Matching placebo |
Timeline
- Start date
- 2018-12-19
- Primary completion
- 2019-10-31
- Completion
- 2019-10-31
- First posted
- 2019-01-07
- Last updated
- 2022-03-16
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03795142. Inclusion in this directory is not an endorsement.