Trials / Unknown
UnknownNCT06014736
A Phase I Study of XJ101 in Chinese Healthy Subjects
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of XJ101 in Chinese Healthy Subjects
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Starmab biologics（Shanghai）Co,.ltd · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XJ101 for Injection | XJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein. |
| DRUG | Placebo | Placebo contains only excipients. |
Timeline
- Start date
- 2023-08-15
- Primary completion
- 2024-03-26
- Completion
- 2024-09-01
- First posted
- 2023-08-28
- Last updated
- 2024-06-14
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06014736. Inclusion in this directory is not an endorsement.