Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects

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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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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