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| Name | Class |
|---|---|
| AprilBio Co., Ltd. | INDUSTRY |
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This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.
Primary objective of this study will be to evaluate the safety and tolerability of APB-R3 following intravenous (IV) administration of single ascending dose in healthy participants.
The study will consist of 5 planned cohorts (1 cohort per dose level) for a total of up to 31 participants. Cohorts 1 and 2 will include 5 participants each (3 participants receiving the active and 2 participants receiving the placebo). Cohort 3 to Cohort 5 will include 7 participants each (5 participants receiving the active and 2 participants receiving the placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD cohort | Experimental | SAD cohorts 1-5. Randomised participants in each cohort will receive a single IV dose of APB-R3. |
|
| Placebo | Placebo Comparator | SAD cohorts 1-5. 2 randomised participants of each cohort will receive a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APB-R3 | Drug | APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants. | Number of participants with serious and other non-serious adverse events. | Upto 92 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK (Pharmacokinetic) assessment of APB-R3 | AUC0-t will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | AUC0-inf will be assessed. |
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Inclusion Criteria:
Male or female, non-smoker, 18 to 60 years of age (both inclusive),
Healthy as defined by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP | CMAX Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D016706 | Still's Disease, Adult-Onset |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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The study will be double-blinded. The participants and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the participant's treatment assignment (APB-R3 or placebo).
| Placebo | Drug | 0.90% Normal Saline only |
|
| Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | Cmax will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | Tmax will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | Ceoi will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | MRT will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | Residual area will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | T½ el will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | Kel will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | Cl will be assessed. | Upto 92 days |
| PK (Pharmacokinetic) assessment of APB-R3 | Vz will be assessed. | Upto 92 days |
| PD (Pharmacodynamics) effect assessment of APB-R3 | AUEC0-t will be assessed. | Upto 92 days |
| PD (Pharmacodynamics) effect assessment of APB-R3 | Cmax will be assessed. | Upto 92 days |
| PD (Pharmacodynamics) effect assessment of APB-R3 | Tmax will be assessed. | Upto 92 days |
| Immunogenicity assessment of APB-R3 | The percentage of participants with anti-drug antibodies (ADA) to APB-R3 will be assessed. | Upto 92 days |
| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |