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TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ003234 | Experimental | 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion |
|
| Placebo | Placebo Comparator | 0 mg/kg via single IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ003234 | Drug | Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile: AEs | Incidence of Adverse Events (AEs) | Up to 85 days after study drug administration |
| Maximum Tolerated Dose | Determine Maximum Tolerated Dose of TJ003234 | Up to 85 days after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameters: Tmax | Time of peak concentration (Tmax) | Up to 85 days after study drug administration |
| Pharmacokinetic (PK) Parameters: Cmax | Maximal Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Xu, MD, PhD | I-Mab Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| C000711830 | plonmarlimab |
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| Placebo | Drug | Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline |
|
| Up to 85 days after study drug administration |
| Pharmacokinetic (PK) Parameters: T1/2 | Investigational product (IP) half-life (T1/2) | Up to 85 days after study drug administration |
| Pharmacokinetic (PK) Parameters: CL | Investigational Product (IP) Clearance (CL) | Up to 85 days after study drug administration |
| Pharmacokinetic (PK) Parameters: AUC∞ | Area under the curve from time zero extrapolated to infinity (AUC∞) | Up to 85 days after study drug administration |
| Anti-drug antibodies (ADA) | Incidence and concentration of anti-drug antibodies | Up to 85 days after study drug administration |