Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability,pharmacokinetic and pharmacodynamic study of STSA-1002 injection in healthy subjects. A total of 26 healthy subjects were enrolled in three dosage groups.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A low dose of group | Experimental | All subjects will be randomized to receive low dose of STSA-1002 or dose-matched placebo. |
|
| A middle dose of group | Experimental | All subjects will be randomized to receive middle dose of STSA-1002 or dose-matched placebo. |
|
| A high dose of group | Experimental | All subjects will be randomized to receive high dose of STSA-1002 or dose-matched placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSA-1002 Injection | Drug | Intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events、Clinically Significant Laboratory Abnormalities、Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities. | To evaluate the safety and tolerability of multiple intravenous administration of STSA-1002 in healthy adult subjects. | Up to Study Day 56 |
| Maximum plasma concentration (Cmax) | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t) | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Time of maximum concentration (Tmax) | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Elimination half-life (t1/2) | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Mean residence time (MRT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in concentration of free C5a and anti-drug antibody | To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 in healthy subjects | From Day 0 to Day 56 |
| Change from baseline in concentration of Myeloperoxidase(MPO)、Neutrophil elastase(NE)、Proteinase3(PR3)、 C-X-C chemokine receptor 1(CXCR1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xinghe Wang, Ph.D | Beijing Shijitan Hospital, Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital, Capital Medical University | Beijing | Beijing Municipality | 102600 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42394970 | Derived | Fang Y, Wang X, Qi L, Tong Y, Wei Y, Li Z, Liu C, Liu J, Cheng X, Liu X, Liu F, Li Y, Li Y, Liu L, Sun M, Wang Y, Wang X. Safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of STSA-1002, recombinant anti-human C5a fully human monoclonal antibody, in a randomized, first-in-human phase I study in healthy adults. Front Pharmacol. 2026 Jun 18;17:1838620. doi: 10.3389/fphar.2026.1838620. eCollection 2026. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intravenous injection |
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects |
| From Day 0 to Day 56 |
| Clearance (CL) | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Apparent volume of distribution (Vz) | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Maximum Concentration of the Analyte in Plasma at steady state(Cmax, ss) | To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Minimum Measured Concentration of the Analyte in Plasma at Steady State(Cmin, ss) | To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Time-averaged concentration at steady state(Cav, ss) | To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Area under the concentration curve from time 0 extrapolate to infinite time(AUCinf,ss) | To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Degree of fluctuation(DF) | To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
| Accumulation factor | To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects | From Day 0 to Day 56 |
To evaluate the effect of STSA-1002 on MPO、NE、PR3、CXCR1 |
| From Day 0 to Day 56 |
| The Second Affiliated Hospital Of Xingtai Medical College |
| Xingtai |
| Hebei |
| 054000 |
| China |