Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects

R-Pharm

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: RPH-104; Other: Sodium chloride Sterile Injection 0.9% w/v

Study type: Interventional

Funder types: Industry

Identifiers

NCT02667639

RPH104FIH01

Details and patient eligibility

About

The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.

Full description

RPH-104 is a macromolecular compound with a molecular weight of 152.715 kilodalton (Data on file) and is capable of binding human interleukin-1 beta (IL-1β). It has also been shown in vitro to be a highly potent inhibitor of IL-1β signalling pathway, with low picomolar inhibitor activity. In this First in Human study, RPH-104 will be evaluated primarily for its safety and tolerability. In a phase I study conducted with health volunteers, a similar monoclonal antibody, canakinumab, was investigated in terms of pharmacokinetics and pharmacodynamics besides efficacy and safety. Similarly, this aimed to investigate effects of RPH-104 on selected pharmacodynamic parameters, including Anti-Drug Antibodies (ADA) along with obtaining first human data on pharmacokinetics of RPH-104 in humans will be investigated in the same study.

Enrollment: 35 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects.
• Male or female subjects between 18 and 35 years old (inclusive).
• Subject who has normal body weight as determined by a body mass index (BMI) of between 18 kg/m² and 30 kg/m² (inclusive) and within a body weight of ≥50kg and ≤120kg.

Exclusion criteria

• Subject who has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, dermatological, neurological, psychiatric, and hematological or immunological disorder(s), and/or any condition that could constitute a potential safety risk factor or could alter the absorption, distribution, metabolism or elimination of the study drugs.
• Subject who has positive immunoglobulin-M (IgM) antibodies against Epstein-Barr virus (EBV)-viral capsid antigen (VCA) (IgM-anti-EBV-VCA) and Cytomegalovirus (CMV).
• Subject who has a positive Quantiferon TB-Gold (TB) test
• Subject who is positive to Human Immunodeficiency Virus-1/2 antibody (HIV-1/2Ab).
• Subject who has serum hepatitis, or is a carrier of the Hepatitis B surface antigen (HBsAg), or is Hepatitis C virus antibody (HCV-Ab) positive.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) will be administered subcutaneously.

Treatment:

Biological: RPH-104

Placebo

Placebo Comparator group

Description:

A single 0.9% sodium chloride injection will be administered subcutaneously.

Treatment:

Other: Sodium chloride Sterile Injection 0.9% w/v