- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483911
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
July 12, 2018 updated by: Ablynx
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Groningen, Netherlands
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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Single or multiple doses, administered via pulmonary inhalation.
Multiple dosing will consist of twice daily dosing on 5 consecutive days.
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EXPERIMENTAL: ALX-0171
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of treatment-emergent adverse events
Time Frame: until 1 month after last study drug administration
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until 1 month after last study drug administration
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma concentration of ALX-0171
Time Frame: from predose until 5 days after study drug administration
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from predose until 5 days after study drug administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2011
Primary Completion (ACTUAL)
May 1, 2012
Study Completion (ACTUAL)
May 1, 2012
Study Registration Dates
First Submitted
November 30, 2011
First Submitted That Met QC Criteria
November 30, 2011
First Posted (ESTIMATE)
December 2, 2011
Study Record Updates
Last Update Posted (ACTUAL)
July 13, 2018
Last Update Submitted That Met QC Criteria
July 12, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALX-0171-1.1/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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