Back to resultsALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
Primary Purpose
RSV Infection
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
ALX-0171
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for RSV Infection
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ALX-0171
Placebo
Arm Description
Outcomes
Primary Outcome Measures
number of treatment-emergent adverse events
Secondary Outcome Measures
plasma concentration of ALX-0171
Full Information
NCT ID
NCT01483911
First Posted
November 30, 2011
Last Updated
July 12, 2018
Sponsor
Ablynx, a Sanofi company
1. Study Identification
Unique Protocol Identification Number
NCT01483911
Brief Title
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ablynx, a Sanofi company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALX-0171
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
ALX-0171
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single or multiple doses, administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.
Primary Outcome Measure Information:
Title
number of treatment-emergent adverse events
Time Frame
until 1 month after last study drug administration
Secondary Outcome Measure Information:
Title
plasma concentration of ALX-0171
Time Frame
from predose until 5 days after study drug administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josefin-Beate Holz, MD
Organizational Affiliation
Ablynx, a Sanofi company
Official's Role
Study Director
Facility Information:
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
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