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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
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This study is a Phase Ia, single-center, randomized, double-blind, dose-escalation, placebo-controlled clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile of ACT100 in healthy participants. A total of 6 dose cohorts are planned, with each cohort enrolling 8 participants (including both male and female participants, where 6 will receive the investigational drug and 2 will receive placebo). The total planned enrollment is 48 healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT100 Cohort 1 | Experimental |
| |
| Placebo Group for Cohort 1 | Placebo Comparator |
| |
| ACT100 Cohort 2 | Experimental |
| |
| Placebo Group for Cohort 2 | Placebo Comparator |
| |
| ACT100 Cohort 3 | Experimental |
| |
| Placebo Group for Cohort 3 | Placebo Comparator |
| |
| ACT100 Cohort 4 | Experimental |
| |
| Placebo Group for Cohort 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT100 Injection | Drug | a single 5-mg subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(AE) | Day 1-84 | |
| Serious Adverse Event | Day 1-84 | |
| blood pressure | Day 1-84 | |
| pulse | Day 1-84 | |
| respiration | Day 1-84 | |
| body temperature | Day 1-84 | |
| Number of Participants with Abnormal Physical examination parameters | Day 1-84 | |
| Number of Participants with Abnormal Laboratory Parameters Findings | Day 1-84 | |
| Number of Participants with 12-Lead Electrocardiogram Findings | Day 1-84 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the plasma concentration-time Curve from time zero to the last measurable concentration(AUCâ‚€-t) | Day 1-4,7,14,21,28,42,56,70,84 | |
| Area Under the plasma concentration-time Curve from time zero extrapolated to infinity(AUC₀-∞) | Day 1-4,7,14,21,28,42,56,70,84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohong Han | Contact | 050-69154796 | hanxiaohong@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohong Han | Peking Union Medical College Hospital | Principal Investigator |
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| Placebo Comparator |
|
| ACT100 Cohort 5 | Experimental |
|
| Placebo Group for Cohort 5 | Placebo Comparator |
|
| ACT100 Cohort 6 | Experimental |
|
| Placebo Group for Cohort 6 | Placebo Comparator |
|
| Placebo for ACT100 |
| Drug |
a single 5-mg subcutaneous injection |
|
| ACT100 Injection | Drug | a single 25-mg subcutaneous injection |
|
| Placebo for ACT100 | Drug | a single 25-mg subcutaneous injection |
|
| ACT100 Injection | Drug | a single 100-mg subcutaneous injection |
|
| Placebo for ACT100 | Drug | a single 100-mg subcutaneous injection |
|
| ACT100 Injection | Drug | a single 300-mg subcutaneous injection |
|
| Placebo for ACT100 | Drug | a single 300-mg subcutaneous injection |
|
| ACT100 Injection | Drug | a single 600-mg subcutaneous injection |
|
| Placebo for ACT100 | Drug | a single 600-mg subcutaneous injection |
|
| ACT100 Injection | Drug | a single 800-mg subcutaneous injection |
|
| Placebo for ACT100 | Drug | a single 800-mg subcutaneous injection |
|
| Maximum observed plasma concentration(Cmax) | Day 1-4,7,14,21,28,42,56,70,84 |
| Time to reach the maximum observed plasma concentration(Tmax) | Day 1-4,7,14,21,28,42,56,70,84 |
| Terminal elimination half-life(t1/2) | Day 1-4,7,14,21,28,42,56,70,84 |
| Apparent clearance (CL/F) | Day 1-4,7,14,21,28,42,56,70,84 |
| Apparent volume of distribution(Vd/F) | Day 1-4,7,14,21,28,42,56,70,84 |
| Levels of BDCA2 on the surface of plasmacytoid dendritic cells (pDCs) | Day 1-3,7,14,28,42,56,70,84 |
| Peripheral blood pDC levels | Day 1-3,7,14,28,42,56,70,84 |
| Anti-drug antibodies (ADA). | Day 1,28,56,84 |
| Neutralizing antibodies (NAb) | Day 1,28,56,84 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
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