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

Still's Disease, Adult-Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05715736
• Other study ID #: APB-R3-101
• Status: Completed
• Phase: Phase 1
• Start date: March 8, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: February 2023
• Source: Syneos Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Still's Disease, Adult-Onset

Intervention

Drug:
• APB-R3
APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously.
• Placebo
0.90% Normal Saline only

Locations

Country	Name	City	State
Australia	CMAX Clinical Research	Adelaide	South Australia

Sponsors (2)

Lead Sponsor	Collaborator
Syneos Health	AprilBio Co., Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK (Pharmacokinetic) assessment of APB-R3	AUC0-t will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	AUC0-inf will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	Cmax will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	Tmax will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	Ceoi will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	MRT will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	Residual area will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	T½ el will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	Kel will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	Cl will be assessed.	Upto 92 days
Secondary	PK (Pharmacokinetic) assessment of APB-R3	Vz will be assessed.	Upto 92 days
Secondary	PD (Pharmacodynamics) effect assessment of APB-R3	AUEC0-t will be assessed.	Upto 92 days
Secondary	PD (Pharmacodynamics) effect assessment of APB-R3	Cmax will be assessed.	Upto 92 days
Secondary	PD (Pharmacodynamics) effect assessment of APB-R3	Tmax will be assessed.	Upto 92 days
Secondary	Immunogenicity assessment of APB-R3	The percentage of participants with anti-drug antibodies (ADA) to APB-R3 will be assessed.	Upto 92 days