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

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Still's Disease, Adult-Onset

Clinical Trial Details

NCT number	NCT05715736
Study type	Interventional
Source	Syneos Health
Contact
Status	Completed
Phase	Phase 1
Start date	March 8, 2023
Completion date	December 19, 2023

View Details

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