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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002994-27 | EudraCT Number |
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| Name | Class |
|---|---|
| SGS Life Sciences, a division of SGS Belgium NV | OTHER |
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The goal of this clinical trial is to assess the safety, tolerability and blood levels following a single dose or after multiple doses of CK-0045 given subcutaneously to healthy participants or otherwise healthy participants with obesity. 76 participants will receive CK-0045 or matching placebo at different escalating doses in 2 study parts: 40 healthy participants will receive a single dose and 36 otherwise healthy participants with obesity will receive 6 doses one week apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending dose (SAD) CK-0045 Dose level 1 to 5 | Experimental | At each dose level 6 healthy participants will receive a single dose of CK-0045 by s.c. administration |
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| SAD placebo | Placebo Comparator | At each dose level 2 healthy participants will receive a single dose of matching placebo by s.c. administration |
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| Multiple ascending dose (MAD) CK-0045 Dose level 1 to 3 | Experimental | At each dose level 9 otherwise healthy participants with obesity will receive a loading dose of CK-0045 on Day 1 followed by a dose on Day 8, Day 15, Day 22, Day 29 and Day 36 of CK-0045 by s.c. administration |
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| MAD placebo | Placebo Comparator | At each dose level 3 otherwise healthy participants with obesity will receive matching placebo on Day 1, Day 8 , Day 15, Day 22, Day 29 and Day 36 by s.c. administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CK-0045 | Drug | Interleukin-22 agonist |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity and seriousness of treatment emergent adverse events | The safety and tolerability following single and multiple ascending doses of CK-0045 will be assessed | Up to 8 weeks after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | The Cmax following single and multiple ascending doses of CK-0045 will be characterized | Day 1 to 8 weeks after last dose |
| Area under the serum concentration-time curve from 0 to 168 hours (AUC168) after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Louise Kjølbye, PhD | Cytoki Pharma | Study Director |
| Lotte Verwillingen, MD | SGS Clinical Research, Clinical Pharmacology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Clinical Research, Clinical Pharmacology Unit | Edegem | 2650 | Belgium |
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| Placebo | Drug | Matching placebo |
|
AUC168 following single and multiple ascending doses of CK-0045 will be characterized |
| Day 1 to Day 8 |
| Area under the serum concentration-time curve from 0 to infinity (AUCinf) | AUCinf following single and multiple ascending doses of CK-0045 will be characterized | Day 1 to 8 weeks after last dose |