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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-12-19

Brief Summary

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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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Detailed Description

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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).

Conditions

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Still's Disease, Adult-Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study will be double-blinded. The participants and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the participant's treatment assignment (APB-R3 or placebo).

Study Groups

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SAD cohort

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

Group Type EXPERIMENTAL

APB-R3

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.90% Normal Saline only

Interventions

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APB-R3

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

Intervention Type DRUG

Placebo

0.90% Normal Saline only

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes