Still's Disease, Adult-Onset
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGAPB-R3
APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously.
DRUGPlacebo
0.90% Normal Saline only
Sponsors
AprilBio Co., Ltd.
Syneos Health
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, non-smoker, 18 to 60 years of age (both inclusive), 2. Healthy as defined by: 1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease in the opinion of the investigator.
Exclusion criteria
1. Abnormal finding at physical examination 2. Evidence of clinical significant hepatic or renal impairment 3. Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, or positive test results for COVID-19, or QuantiFERON®-TB test at screening. 4. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants. | Upto 92 days | Number of participants with serious and other non-serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK (Pharmacokinetic) assessment of APB-R3 | Upto 92 days | AUC0-t will be assessed. |
| PD (Pharmacodynamics) effect assessment of APB-R3 | Upto 92 days | AUEC0-t will be assessed. |
| Immunogenicity assessment of APB-R3 | Upto 92 days | The percentage of participants with anti-drug antibodies (ADA) to APB-R3 will be assessed. |
Countries
Australia
Outcome results
None listed