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This is a double-blind, randomized, placebo-controlled, single ascending dose (SAD) study to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of DF5112 in healthy adult participants. A total of 48 participants are planned to be randomized into 6 cohorts. Additional cohorts at intermediate dose levels may be evaluated. Each cohort will include 8 healthy participants randomized to receive DF5112 or placebo through intravenous (IV) or subcutaneous (SC) administration. Following dose administration participants will be confined at the clinical research unit for observation for approximately 1 week and then will return for subsequent pre-identified follow up visits through Day 29.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DF5112 | Experimental | Single dose of DF5112 administered either via IV or SC |
|
| Placebo | Placebo Comparator | Single dose of placebo administered either via IV or SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DF5112 | Drug | DF5112 administered IV or SC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | From Day 1 dosing to end of study at Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the PK of single ascending doses of DF5112 administered by IV or SC injection | PK parameter: Area Under the Concentration Curve (AUC) | From Day 1 dosing to end of study at Day 29 |
| Incidence and titer of Anti-Drug Antibodies |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Argent | Contact | +61 2 9382 5844 | christopher.argent@scientiaclinicalresearch.com.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research Ltd | Recruiting | Sydney | New South Wales | 2031 | Australia |
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Double-blind
| Other |
Placebo administered IV or SC. |
|
| From Day 1 dosing to end of study at Day 29 |