Status:
COMPLETED
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
Lead Sponsor:
Ablynx, a Sanofi company
Conditions:
RSV Infection
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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-01...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01483911
Start Date
November 1 2011
End Date
May 1 2012
Last Update
July 13 2018
Active Locations (1)
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1
Groningen, Netherlands