Clinical trial

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

Name

APB-R3-101

Description

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.

Trial arms

Trial start

2023-03-08

Estimated PCD

2023-12-19

Trial end

2023-12-19

Status

Completed

Phase

Early phase I

Treatment

APB-R3

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

Arms:

SAD cohort

Placebo

0.90% Normal Saline only

Arms:

Placebo

Size

Primary endpoint

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

Upto 92 days

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "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).", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

Updated at

2024-01-08

1 organization

1 product

1 drug

2 indications

Organization

Product

Indication

Indication

Drug