NCT05715736

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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).

Conditions

• Still's Disease, Adult-Onset

Interventions

Type	Name	Description
DRUG	APB-R3	APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously.
DRUG	Placebo	0.90% Normal Saline only

Timeline

• Start date: 2023-03-08
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2023-02-08
• Last updated: 2024-01-08

Locations

1 site across 1 country: Australia