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CompletedNCT05715736Updated Jan 8, 2024

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

A Phase 1 interventional study of APB-R3 and Placebo in Still's Disease, Adult-Onset, sponsored by Syneos Health. Completed at 1 site in Australia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-08.

Sponsored by Syneos Health · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

Read the 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).

02

Conditions studied

  • Still's Disease, Adult-Onset
03

In context

Still's Disease, Adult-Onset

24 studies on the registry are indexed under Still's Disease, Adult-Onset; 5 are open to participants now.

This study's enrollment of 31 is above the median of 14 across 12 interventional studies indexed under Still's Disease, Adult-Onset.

Browse Still's Disease, Adult-Onset studies →

Lead sponsor

Syneos Health is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    SAD cohort

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

    Drug: APB-R3

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugAPB-R3

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

  • DrugPlacebo

    0.90% Normal Saline only

06

What researchers measure

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.

    Time frame: Upto 92 days

Secondary outcomes

  1. PK (Pharmacokinetic) assessment of APB-R3

    AUC0-t will be assessed.

    Time frame: Upto 92 days

  2. PK (Pharmacokinetic) assessment of APB-R3

    AUC0-inf will be assessed.

    Time frame: Upto 92 days

  3. PK (Pharmacokinetic) assessment of APB-R3

    Cmax will be assessed.

    Time frame: Upto 92 days

  4. PK (Pharmacokinetic) assessment of APB-R3

    Tmax will be assessed.

    Time frame: Upto 92 days

  5. PK (Pharmacokinetic) assessment of APB-R3

    Ceoi will be assessed.

    Time frame: Upto 92 days

  6. PK (Pharmacokinetic) assessment of APB-R3

    MRT will be assessed.

    Time frame: Upto 92 days

  7. PK (Pharmacokinetic) assessment of APB-R3

    Residual area will be assessed.

    Time frame: Upto 92 days

  8. PK (Pharmacokinetic) assessment of APB-R3

    T½ el will be assessed.

    Time frame: Upto 92 days

  9. PK (Pharmacokinetic) assessment of APB-R3

    Kel will be assessed.

    Time frame: Upto 92 days

  10. PK (Pharmacokinetic) assessment of APB-R3

    Cl will be assessed.

    Time frame: Upto 92 days

  11. PK (Pharmacokinetic) assessment of APB-R3

    Vz will be assessed.

    Time frame: Upto 92 days

  12. PD (Pharmacodynamics) effect assessment of APB-R3

    AUEC0-t will be assessed.

    Time frame: Upto 92 days

  13. PD (Pharmacodynamics) effect assessment of APB-R3

    Cmax will be assessed.

    Time frame: Upto 92 days

  14. PD (Pharmacodynamics) effect assessment of APB-R3

    Tmax will be assessed.

    Time frame: Upto 92 days

  15. Immunogenicity assessment of APB-R3

    The percentage of participants with anti-drug antibodies (ADA) to APB-R3 will be assessed.

    Time frame: Upto 92 days

07

Study locations

1 site
  • CMAX Clinical Research
    Adelaide, South Australia 5000, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05715736
Lead sponsor
Syneos Health
Collaborators
AprilBio Co., Ltd.
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Mar 8, 2023
Primary completion
Dec 19, 2023
Completion
Dec 19, 2023
Last update
Jan 8, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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