A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

Ablynx

Status and phase: Completed; Phase 2; Phase 1

Conditions: Respiratory Syncytial Virus Infection

Treatments: Other: Placebo; Biological: ALX-0171

Study type: Interventional

Funder types: Industry

Identifiers

NCT02309320

ALX0171-C104

2014-002841-23 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to investigate the safety and tolerability of ALX-0171.

The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.

Enrollment: 53 patients

Sex: All

Ages: 28 days to 23 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)
2. Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV
3. Subject has a positive RSV diagnostic test
4. Others as defined in the protocol

Exclusion criteria

1. Subject has history of wheezing
2. Subject is known to have significant comorbidities
3. Subject is known to be immunocompromised
4. Subject is suspected of having a clinically relevant infection other than RSV
5. Others as defined in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

53 participants in 2 patient groups, including a placebo group

ALX-0171

Experimental group

Description:

Inhalation of ALX-0171 during 3 consecutive days

Treatment:

Biological: ALX-0171

Placebo

Placebo Comparator group

Description:

Inhalation of Placebo during 3 consecutive days

Treatment:

Other: Placebo