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

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

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.

Study Overview

• Status: Completed
• Conditions: Still's Disease, Adult-Onset
• Intervention / Treatment: Drug: APB-R3; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Syneos Health
• Collaborators: AprilBio Co., Ltd.
• Investigators: Principal Investigator: Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP, CMAX Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): December 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Still's Disease, Adult-Onset
• Other Study ID Numbers: APB-R3-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No