Clinical trial NCT05715736: Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Still's Disease, Adult-Onset
Lead sponsor: Syneos Health
Sponsor class: OTHER
Collaborators: name: AprilBio Co., Ltd.
First posted: 2023-02-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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:

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.

Primary outcomes:
measure: To evaluate the safety and tolerability of APB-R3 following IV administration of single ascending dose in healthy participants.
timeFrame: Upto 92 days
Secondary outcomes:
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PK (Pharmacokinetic) assessment of APB-R3
timeFrame: Upto 92 days
measure: PD (Pharmacodynamics) effect assessment of APB-R3
timeFrame: Upto 92 days
measure: PD (Pharmacodynamics) effect assessment of APB-R3
timeFrame: Upto 92 days
measure: PD (Pharmacodynamics) effect assessment of APB-R3
timeFrame: Upto 92 days
measure: Immunogenicity assessment of APB-R3
timeFrame: Upto 92 days
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
affiliation: CMAX Clinical Research
name: Nicholas Farinola, B.Sc (Biomed. Sci.),BMBS,FRACP
role: PRINCIPAL_INVESTIGATOR
References: