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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003991-15 | EudraCT Number |
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Due to occurrence of eye related adverse events.
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The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of SRK-001 in Healthy Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRK-001- Dose 1 | Experimental | Participants will receive intravenous (IV) SRK-001 every 2 weeks (Q2W) for 4 doses. |
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| SRK-001- Dose 2 | Experimental | Participants will receive IV SRK-001 every 4 weeks (Q4W) for 2 doses. |
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| SRK-001- Dose 3 | Experimental | Participants will receive IV SRK-001 Q2W for 4 doses. |
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| Placebo | Placebo Comparator | Participants will receive IV placebo Q2W for 4 doses or Q4W for 2 doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRK-001 | Drug | Participants will receive IV doses of SRK-001. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) | Number of participants with one or more TEAEs and SAEs will be reported in the adverse events module. | Baseline through final follow-up at approximately Day 155 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve During a Dosing Interval (AUC0-tau) at Steady State | Pharmacokinetics (PK) after single and multiple IV dosing. | Day 1 (End of the infusion [EOI]) up to Day 155 post EOI |
| Half-Life (t1/2) |
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Inclusion Criteria:
Participants who have clinical chemistry laboratory values within the acceptable range for the population, as per the investigator judgment
Body mass index of 18 to 32 kilogram (kg)/ square meter (m^2)
Healthy male participants
Healthy female participants of childbearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from screening to 90 days after the last dose of the study intervention. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:
Has been fully vaccinated for COVID-19 with the last dose of vaccine administered at least 3 weeks prior to study intervention administration
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Sarkana Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands |
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| Placebo | Drug | Participants will receive IV doses of placebo. |
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PK after single and multiple IV dosing.
| Day 1 (EOI) up to Day 155 post EOI |
| Concentrations at End of Infusion (Cmax) | PK after single and multiple IV dosing. | Day 1 (EOI) up to Day 155 post EOI |
| Concentrations at End of Dosing Interval (Ctrough) | PK after single and multiple IV dosing. | Day 1 (EOI) up to Day 155 post EOI |