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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

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.

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Detailed Description

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Conditions

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RSV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ALX-0171

Group Type EXPERIMENTAL

ALX-0171

Intervention Type BIOLOGICAL

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Single or multiple doses, administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.

Interventions

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ALX-0171

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

Placebo

Single or multiple doses, administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes