Phase 1
Completed N=35
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT02667639 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Adverse Events — 0; 0 participants
Summary
The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
0; 0 | — |
| PRIMARY Serious Adverse Events |
0; 0 | — |
| PRIMARY Respiratory Rate |
0; 0 | — |
| PRIMARY Blood Pressure |
0; 0 | — |
| PRIMARY Oxygen Saturation |
0; 0 | — |
| PRIMARY Body Temperature |
0; 0 | — |
| PRIMARY Clinical Laboratory Tests |
0; 0 | — |
| SECONDARY RPH-104 - Area Under the Curve (AUC) |
74500; 0; 430000; 0; 661000; 0 | — |
| SECONDARY RPH-104 - Time to Maximum Concentration (Tmax) |
96; 0; 96; 0; 120; 0 | — |
| SECONDARY RPH-104 - Elimination Half-life (t1/2) |
245; 0; 249; 0; 255; 0 | — |
| SECONDARY RPH-104 - Maximum Plasma Concentration (Cmax) |
198; 0; 1280; 0; 1650; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02667639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.