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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05715736




Registration number
NCT05715736
Ethics application status
Date submitted
17/08/2022
Date registered
8/02/2023

Titles & IDs
Public title
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3
Scientific 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
Secondary ID [1] 0 0
APB-R3-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Still's Disease, Adult-Onset 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - APB-R3
Treatment: Drugs - Placebo

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

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


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

Treatment: Drugs: Placebo
0.90% Normal Saline only
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants.
Timepoint [1] 0 0
Upto 92 days
Secondary outcome [1] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [1] 0 0
Upto 92 days
Secondary outcome [2] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [2] 0 0
Upto 92 days
Secondary outcome [3] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [3] 0 0
Upto 92 days
Secondary outcome [4] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [4] 0 0
Upto 92 days
Secondary outcome [5] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [5] 0 0
Upto 92 days
Secondary outcome [6] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [6] 0 0
Upto 92 days
Secondary outcome [7] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [7] 0 0
Upto 92 days
Secondary outcome [8] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [8] 0 0
Upto 92 days
Secondary outcome [9] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [9] 0 0
Upto 92 days
Secondary outcome [10] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [10] 0 0
Upto 92 days
Secondary outcome [11] 0 0
PK (Pharmacokinetic) assessment of APB-R3
Timepoint [11] 0 0
Upto 92 days
Secondary outcome [12] 0 0
PD (Pharmacodynamics) effect assessment of APB-R3
Timepoint [12] 0 0
Upto 92 days
Secondary outcome [13] 0 0
PD (Pharmacodynamics) effect assessment of APB-R3
Timepoint [13] 0 0
Upto 92 days
Secondary outcome [14] 0 0
PD (Pharmacodynamics) effect assessment of APB-R3
Timepoint [14] 0 0
Upto 92 days
Secondary outcome [15] 0 0
Immunogenicity assessment of APB-R3
Timepoint [15] 0 0
Upto 92 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2023
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AprilBio Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05715736