Trials / Completed
CompletedNCT05542303
A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects
A Single Ascending Dose, Safety, and Pharmacokinetic Study of ZB001 in Healthy Chinese Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Zenas BioPharma (USA), LLC · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of ZB001 in healthy Chinese subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZB001 for injection | Dose Cohort1 (3mg/kg) ZB001 of single IV injection |
| DRUG | ZB001 for injection | Dose Cohort2 (10mg/kg) ZB001 of single IV injection |
| DRUG | ZB001 for injection | Dose Cohort3 (20mg/kg) ZB001 of single IV injection |
Timeline
- Start date
- 2022-10-16
- Primary completion
- 2023-04-04
- Completion
- 2023-04-04
- First posted
- 2022-09-15
- Last updated
- 2025-04-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05542303. Inclusion in this directory is not an endorsement.