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

Ablynx

Status and phase

Completed

Phase 1

Conditions

RSV Infection

Treatments

Biological: Placebo

Biological: ALX-0171

Study type

Interventional

Funder types

Industry

Identifiers

NCT01483911

ALX-0171-1.1/11

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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