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

Phase 1

Completed

• Conditions: Still's Disease, Adult-Onset
• Interventions: Drug: APB-R3; Drug: Placebo

• Registration Number: NCT05715736
• Lead Sponsor: Syneos Health

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).

Study Timeline

• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2023-01-27
• Status Verified: 2023-02
• Study First Posted: 2023-02-08
• Study Start: 2023-03-08
• Primary Completion: 2023-12-19
• Study Completion: 2023-12-19
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD cohort	APB-R3	SAD cohorts 1-5. Randomised participants in each cohort will receive a single IV dose of APB-R3.
Placebo	Placebo	SAD cohorts 1-5. 2 randomised participants of each cohort will receive a placebo.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PK (Pharmacokinetic) assessment of APB-R3	Upto 92 days	Vz 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.
PD (Pharmacodynamics) effect assessment of APB-R3	Upto 92 days	Tmax will be assessed.

Trial Locations

Locations (1)

CMAX Clinical Research; 🇦🇺 Adelaide, South Australia, Australia