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

NCT05715736 | Completed Phase 1

• 1 other identifier: APB-R3-101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Still's Disease, Adult-Onset

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• PK (Pharmacokinetic) assessment of APB-R3

  Upto 92 days

• PK (Pharmacokinetic) assessment of APB-R3

  Upto 92 days

• PK (Pharmacokinetic) assessment of APB-R3

  Upto 92 days

• PK (Pharmacokinetic) assessment of APB-R3

  Upto 92 days

• PK (Pharmacokinetic) assessment of APB-R3

  Upto 92 days

Study Arms (2)

SAD cohort

EXPERIMENTAL

SAD cohorts 1-5. Randomised participants in each cohort will receive a single IV dose of APB-R3.

Drug: APB-R3

Placebo

PLACEBO COMPARATOR

SAD cohorts 1-5. 2 randomised participants of each cohort will receive a placebo.

Drug: Placebo

Interventions

APB-R3 DRUG

APB-R3 is formulated as a sterile solution containing APB-R3 as the active substance administered intravenously.

SAD cohort

Placebo DRUG

0.90% Normal Saline only

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, non-smoker, 18 to 60 years of age (both inclusive),
• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator.
• 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.

You may not qualify if:

• Abnormal finding at physical examination
• Evidence of clinical significant hepatic or renal impairment
• 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.
• Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.

Sponsors & Collaborators

• Syneos Health: lead
• AprilBio Co., Ltd.: collaborator

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Still's Disease, Adult-Onset

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be double-blinded. The participants and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the participant's treatment assignment (APB-R3 or placebo).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: February 8, 2023
• Study Start: March 8, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: January 8, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)