NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers

CompletedPhase 1

Sponsor: Ablynx, a Sanofi company

Conditions: RSV Infection

Interventions: ALX-0171, Placebo

Countries: Netherlands

ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The purpose of this first-in-man study is to determine the safety, tolerability and pharmacokinetics (PK) of ALX-0171 after single and multiple pulmonary administrations in healthy male volunteers.

Eligibility overview

Sex: MALE

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Non-smoking healthy male volunteers, aged 18-55 years
* Good health condition, as determined by medical history, physical examination and clinical laboratory testing
* Forced expiratory volume in 1 second (FEV1) ≥ 90% of predicted value
* Diffusing capacity of the lung for CO (DLCO) ≥ 85% of predicted value
* Normal chest X-Ray (anteroposterior and lateral view)
* Minimum weight of 70.0 kg, minimum height of 1m70, body mass index between 18.0 and 30.0 kg/m²

Exclusion Criteria:

* Current smokers, or ex-smokers abstinent from tobacco for less than one year
* History or presence of atopy or pulmonary non-specific hyperreactivity
* Positive bronchial challenge test
* Symptomatic viral infection, or suspicion thereof (including rhinitis) in last 14 days prior to dosing
* Signs of active pulmonary infection or other inflammatory conditions, even in the absence of febrile episodes, in the last 14 days prior to dosing

Locations (1)

Groningen, Netherlands