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ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers

Phase I, Single-centre, Open-label Study to Evaluate the Pharmacokinetics of ALX-0171, Administered by Oral Inhalation or Intravenously, in Healthy Male Volunteers

NCT01875926•Ablynx, a Sanofi company

View on ClinicalTrials.gov

Summary

The overall aims of the study are: * To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i) local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentrations of ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations after intravenous administration. * To further determine the safety and local and systemic tolerability of ALX-0171. * To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Non-smoking healthy male volunteers, (18-55 years, extremes included).
•2. Good health condition, as determined by medical history, physical examination and clinical laboratory testing
•3. Body mass index (BMI) within normal range: 18.0 ≤ BMI \< 30.0 (kg/m2)
•4. Haematology and chemistry parameters within normal range, or showing no clinically relevant deviations (as judged by the Investigator)
•5. Heart rate and/or blood pressure within normal range (as judged by the Investigator)
•6. Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations (as judged by the Investigator)
•7. Negative urine test for selected drugs of abuse at screening
•8. Negative alcohol breath test upon check-in at study unit
•9. Negative hepatitis panel (including hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus antibodies (anti-HCV)), and negative human immunodeficiency virus (HIV) antibody screens
•10. Willingness to consent to using an effective contraceptive method (by using 2 methods of contraception in combination with a female partner: at least 1 of the contraception methods must be a barrier contraception method, e.g., condom) during the study and for at least 3 months after last study drug administration
+6 more criteria

Exclusion Criteria

•1. Current smokers, or ex-smokers abstinent from tobacco for less than one year, or a history of smoking more than 10 packs a year
•2. Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14 days prior to dosing
•3. Signs of active pulmonary infection or other pulmonary inflammatory conditions, even in the absence of febrile episodes, in the last 14 days prior to dosing
•4. History or presence of disease in the kidneys and/or heart, lungs, liver, gastrointestinal tract, endocrine organs or other conditions such as metabolic disease known to interfere with the absorption, distribution, metabolism or excretion of drugs
•5. Malignancy, or prior malignancy, with a disease-free interval of \< 5 years after diagnosis and intervention, except basal cell carcinoma (treated curatively)
•6. Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis.
•7. History of hypersensitivity or allergies to any drug compound, including constituents of ALX-0171
•8. History of previous administration of ALX-0171, or any other inhaled biologic or drug targeting the Respiratory Syncytial Virus (RSV) F protein. In any other case of use of biologics: at least 6 months before administration of first study medication, or the time of duration of the pharmacodynamic effect, or 10 times the half-life of the respective drug, whatever is longer
•9. Receipt of any investigational drug within 60 days prior to dosing
•10. Intake of prescribed or over-the-counter medication within 14 days prior to dosing (≤ 3 g/day paracetamol is allowed)
+9 more criteria

Locations (1)

Antwerp, Belgium

Key Dates

Start Date

May 1, 2013

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

July 13, 2018

Enrollment

ACTUAL participants

Conditions

HealthyRSV Infection

Interventions

ALX-0171

BIOLOGICAL

ALX-0171

BIOLOGICAL

ALX-0171

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 13, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers

Inclusion Criteria

Exclusion Criteria

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