Trials / Completed
CompletedNCT04784312
A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection
A Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Immunogenicity of a Single Dose of MW14 Injection in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, first time in human study enrolling approximately 42 healthy adult subjects (18-45 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MW14 in healthy adult volunteers administered as a single IV dose compared with placebo, across 5 cohorts. The 5 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 85 days post dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | 9MW1411 injection | 9MW1411 injection |
| COMBINATION_PRODUCT | 9MW1411 injection placebo | 9MW1411 injection placebo |
Timeline
- Start date
- 2021-04-16
- Primary completion
- 2021-08-17
- Completion
- 2021-08-17
- First posted
- 2021-03-05
- Last updated
- 2022-06-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04784312. Inclusion in this directory is not an endorsement.