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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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RSV Infection

Intervention / Treatment
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* Biological: ALX-0171
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALX-0171<br> | Biological: ALX-0171<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Single or multiple doses, administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of treatment-emergent adverse events |  | until 1 month after last study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentration of ALX-0171 |  | from predose until 5 days after study drug administration |