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Completed

NCT Number: NCT05715736

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

APB-R3

Drug

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

Placebo

Drug

0.90% Normal Saline only

Primary outcomes

  1. To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants.

    Time frame: Upto 92 days

    Number of participants with serious and other non-serious adverse events.

Secondary outcomes

  1. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    AUC0-t will be assessed.

  2. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    AUC0-inf will be assessed.

  3. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    Cmax will be assessed.

  4. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    Tmax will be assessed.

  5. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    Ceoi will be assessed.

  6. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    MRT will be assessed.

  7. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    Residual area will be assessed.

  8. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    T½ el will be assessed.

  9. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    Kel will be assessed.

  10. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    Cl will be assessed.

  11. PK (Pharmacokinetic) assessment of APB-R3

    Time frame: Upto 92 days

    Vz will be assessed.

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

    Time frame: Upto 92 days

    AUEC0-t will be assessed.

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

    Time frame: Upto 92 days

    Cmax will be assessed.

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

    Time frame: Upto 92 days

    Tmax will be assessed.

  15. Immunogenicity assessment of APB-R3

    Time frame: Upto 92 days

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

Sponsors and collaborators

Lead sponsor

Syneos Health

Other

Collaborators

  • AprilBio Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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