ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
Phase I, Single-centre, Randomised, Placebo-controlled, Double-blinded Study, With Single Ascending Dose and Multiple Dose at Maximum Tolerated Dose, Evaluating the Safety, Tolerability and Pharmacokinetics of ALX-0171, Administered by Pulmonary Inhalation, in Healthy Male Volunteers
1 other identifier
interventional
60
1 country
1
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-0171 after single and multiple pulmonary administrations in healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 13, 2018
July 1, 2018
6 months
November 30, 2011
July 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
number of treatment-emergent adverse events
until 1 month after last study drug administration
Secondary Outcomes (1)
plasma concentration of ALX-0171
from predose until 5 days after study drug administration
Study Arms (2)
ALX-0171
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Single or multiple ascending doses (2.1-210 mg), administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.
Single or multiple doses, administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Groningen, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Josefin-Beate Holz, MD
Ablynx, a Sanofi company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 2, 2011
Study Start
November 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
July 13, 2018
Record last verified: 2018-07