Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A 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

Conditions
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Still's Disease, Adult-Onset

Intervention / Treatment
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* Drug: APB-R3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, non-smoker, 18 to 60 years of age (both inclusive), Healthy as defined by: the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator. 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: Abnormal finding at physical examination Evidence of clinical significant hepatic or renal impairment 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. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAD cohort<br>SAD cohorts 1-5. Randomised participants in each cohort will receive a single IV dose of APB-R3. | Drug: APB-R3<br>* APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously.<br>|
| Placebo Comparator: Placebo<br>SAD cohorts 1-5. 2 randomised participants of each cohort will receive a placebo. | Drug: Placebo<br>* 0.90% Normal Saline only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |