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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509929-51-00 | EU Trial (CTIS) Number | ||
| 2023-509929-51 | EudraCT Number | ||
| U1111-1305-8892 | Other Identifier | World Health Organisation, WHO, UTN number |
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The primary object in this research study is to investigate the safety and tolerability of ZP9830 in healthy study participants, and in addition, the study will investigate how ZP9830 works in the body (pharmacokinetics, PK and pharmacodynamics, PD) compared to placebo.
SAD Part A: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.
SAD Part B: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety, PK and PD will be assessed.
SAD Part C: Participants will receive 1 dose either ZP9830 or placebo as intravenous (i.v.) dose, and safety and PK will be assessed.
MAD Part: Participants will receive multiple doses of either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZP9830 | Experimental | Up to 10 SAD cohorts planned: Part A, 3 cohorts of each 8 participants with 6 participants receiving s.c. active treatment of ZP9830. Part B, 6 cohorts of each 10 participants with 8 participants receiving s.c. active treatment of ZP9830. Part C, 1 cohort of 8 participants with 6 participants receiving i.v. active treatment of ZP9830 Up to 4 MAD cohorts planned: 4 cohorts of each 8 participants with 6 participants receiving s.c. active treatment of ZP9830. |
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| Placebo | Placebo Comparator | SAD: In each of the 10 single dose cohorts, 2 subjects will receive placebo MAD: In each of the 4 multiple dose cohorts, 2 subjects will receive placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZP9830 | Drug | SAD: Participants will receive 1 single dose of ZP9830 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort. MAD: Participants will receive multiple doses of ZP9830 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Incident of Treatment Emergent Adverse Events (TEAEs) | Treatment Emergent Adverse Events (TEAEs) from baseline to follow-up | From dosing of ZP9830 (Day 1) to follow-up (SAD: Day 29, MAD: Day 41) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information desk | Contact | +45 88 77 36 00 | clinicaltrials@zealandpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Zealand Pharma A/S | Zealand Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Recruiting | Leiden | CL | 2333 | Netherlands |
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Parallel (active or placebo), sequential (dose escalation)
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| Placebo | Drug | SAD: Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Volume will be matching the active treatment. MAD: Participants will receive multiple doses of placebo given subcutaneously (s.c., under the skin). Volume will be matching the active treatment. |
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