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

Syneos Health

Status and phase: Completed; Phase 1

Conditions: Still's Disease, Adult-Onset

Treatments: Drug: APB-R3; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05715736

APB-R3-101

Details and patient eligibility

About

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.

Full 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).

Enrollment: 31 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

SAD cohort

Experimental group

Description:

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

Treatment:

Drug: APB-R3

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo