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
The intent of this study is to evaluate the safety and tolerability of single escalating subcutaneous doses of CUG252 in healthy adult subjects.
This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CUG252 | Experimental | Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers. |
|
| Placebo | Placebo Comparator | Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CUG252 | Drug | CUG252 will be administered by subcutaneous (SC) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects with Treatment Emergent Adverse Events | To evaluate the safety and tolerability of subcutaneous injections of CUG252 in healthy subjects. | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile of CUG252 (AUC) | To assess the Area under the plasma concentration versus time curve (AUC) | Up to 10 weeks |
| Pharmacokinetics profile of CUG252 (Cmax) | To assess the maximum plasma concentration (Cmax) |
Not provided
For healthy subject cohorts,
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin K Kankam, MD, PhD | Altasciences Company Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas, Inc. | Overland Park | Kansas | 66212 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo will be administered by subcutaneous (SC) injection |
|
| Up to 10 weeks |
| Pharmacokinetics profile of CUG252 (Tmax) | To assess the time of maximum concentration (Tmax) | Up to 10 weeks |
| Pharmacokinetics profile of CUG252 (t1/2) | To assess the half-life (t1/2) | Up to 10 weeks |
| Immunogenicity of CUG252 | To measure the serum concentration of antibodies against CUG252 | Up to 10 weeks |
| Change in the number and percentages of immune cells | To assess the effect of CUG252 on immuno-pharmacodynamic endpoints. | Up to 10 weeks |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided