A phase 2a Study in Infants with RSV lower respiratory tract infection, to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of RV521.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 184

Inclusion Criteria

1. Male or female = 1 month and = 36 months of age
2. Weight = 3.5 kg
3. Clinical diagnosis of LRTI defined by
a. Evidence of respiratory infection by one or both of the following with or without fever:
i. Rhinitis/coryza
ii. Cough
AND
b. Evidence of LRTI by the presence of one or more of the following:
i. Increased respiratory rate PLUS other evidence of lower respiratory tract disease (eg, laboratory or radiographic evidence).
ii. Increased respiratory effort as evidenced by one or more of the following:
1. Grunting with expiration
2. Nasal flaring
3. Retraction: intercostal or subcostal
iii. Wheezing: audible or on chest auscultation
4. A positive RSV diagnostic test (RSV infection confirmed either according to routine site practice [polymerase chain reaction or diagnostic quick test], or using a [Sponsor-provided] commercial kit.
5. Hospitalised because of RSV LRTI (bronchiolitis or bronchopneumonia)
6. For Part B, symptoms of LRTI must be present for no more than 1 week before the Screening Visit, with the first day of symptoms counting as Day 1.
7. For Part C, symptoms of LRTI must be present for no more than 5 days prior to the Screening Visit, with the first day of symptoms counting as Day 1.
8. Expected to remain in hospital for a minimum of 3 days (administration of 6 doses for both Parts B and C)
9. The parent(s)/legal guardian(s) of the subject have provided written informed consent for the subject to participate
10. The parent(s)/legal guardian(s) are able and willing to comply with the study protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 184
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Premature (gestational age less than 37 weeks) AND <1 year of post-natal age
2. Known to have significant comorbidities, including genetic disorders (eg, trisomy 21); cardiopulmonary diseases (eg, haemodynamically significant congenital heart disease); pulmonary disease (eg, bronchopulmonary dysplasia, cystic fibrosis); history of surgery for diaphragmatic hernia; any hereditary or acquired metabolic diseases; haematological or other malignancy; or is known to be HIV positive; or has evidence of severe neurologic impairment or developmental delay that would limit the ability to administer study drug or evaluate the safety or clinical response to IMP.
3. Malformation of the gastrointestinal tract including unresolved pyloric stenosis, history of necrotising enterocolitis, short bowel, or other significant condition that would alter drug absorption or increase the risk of diarrhoea.
4. Any clinically significant ECG abnormalities.
5. Known to be immunocompromised
6. High risk of having developing asthma. Features that indicate a high likelihood of asthma in a young child include:
a. Symptoms (cough, wheeze, heavy breathing) for > 10 days during upper respiratory infections
b. > 3 wheezing episodes per year (during the previous 12 months) or severe episodes and/or night wheezing
c. Between episodes, child has cough, wheeze, or heavy breathing during play or when laughing
d. Atopy or family history of asthma in a first degree relative
7. Suspected of having a clinically significant bacterial infection as indicated by symptoms or laboratory findings consistent with a bacterial infection including but not limited to: elevated white blood cell count, elevated C-reactive protein, chest X-ray consistent with bacterial pneumonia, unstable vital signs, hypotension, or evidence of shock or poor perfusion.
8. Has significant oral and/or maxillofacial malformations that would limit the ability to administer IMP.
9. History of renal failure including renal anomalies likely to be associated with renal insufficiency (eg, clinical conditions of renal dysplasia, polycystic renal disease, renal agenesis)
10. Clinical evidence of hepatic decompensation (eg, hepatic disorder with associated coagulopathy or associated encephalopathy) or significantly elevated liver enzymes (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >3 × the upper limit of normal)
11. History of epilepsy or seizures, including febrile seizures
12. Allergy to test medication or constituents
13. Requires any prohibited medication/therapy as listed in the body of the protocol.
a. Receiving treatment with inhaled, oral, or IV corticosteroids and requires continued corticosteroid therapy
b. Has taken within 21 days before dosing, any drug that could impact by any mechanism of action on the PK of the investigational product including any substrates, inducers, inhibitors of CYP3A4 and/or P-glycoprotein (P-gp); or the use of prescription medications, over-the-counter (OTC) medications, herbal remedies or dietary supplements containing St. John’s Wort, or the consumption of drugs or other substances (eg, grapefruit, Seville oranges, or cranberry juice-containing products) known to be potent inhibitors or inducers of CYP P450s.
c. Requires the use of Heliox, Leukotriene receptor antagonist (eg, Montelukast, exogenous surfactant, mucolytics or Hypertonic saline [allowed in the Part A of the study]).
14. Has received 1 or more doses of palivizumab at any time before Screen

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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