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

NCT05715736 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-01-08

No results posted yet for this study

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.

Conditions

  • Still's Disease, Adult-Onset

Interventions

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

Sponsors & Collaborators

  • AprilBio Co., Ltd.

    collaborator INDUSTRY

  • Syneos Health

    lead OTHER

Principal Investigators

  • Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-08
Primary Completion
2023-12-19
Completion
2023-12-19

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05715736 on ClinicalTrials.gov