ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers

NCT01875926 | Completed Phase 1

• 2 other identifiers: ALX-0171-1.3/132013-001425-71
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy; RSV Infection

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples

  Day 1 to Day 9

• Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration

  Day 1 to Day 4

Secondary Outcomes (2)

• Safety and tolerability: safety markers

  from signing of Informed Consent Form (ICF) until last follow-up visit (i.e 35 to 42 days after first study drug administration)

• Immunogenicity: concentration of Anti-Drug Antibodies (ADA)in induced sputum (after oral inhalation only) and serum

  during screening until last follow-up visit (i.e. 35 to 42 days after first study drug administration)

Study Arms (3)

ALX-0171 Oral Inhalation - Single Dose (SD)

EXPERIMENTAL

Biological: ALX-0171

ALX-0171 Oral Inhalation - Multiple Dose (MD)

EXPERIMENTAL

Biological: ALX-0171

ALX-0171 Intravenous (IV)

EXPERIMENTAL

Biological: ALX-0171

Interventions

ALX-0171 BIOLOGICAL

single dose of 200 mg ALX-0171 via oral inhalation

ALX-0171 Oral Inhalation - Single Dose (SD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking healthy male volunteers, (18-55 years, extremes included).
• Good health condition, as determined by medical history, physical examination and clinical laboratory testing
• Body mass index (BMI) within normal range: 18.0 ≤ BMI \< 30.0 (kg/m2)
• Haematology and chemistry parameters within normal range, or showing no clinically relevant deviations (as judged by the Investigator)
• Heart rate and/or blood pressure within normal range (as judged by the Investigator)
• Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations (as judged by the Investigator)
• Negative urine test for selected drugs of abuse at screening
• Negative alcohol breath test upon check-in at study unit
• 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
• 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
• Ability to comprehend and willingness to sign an Informed Consent Form (ICF)
• For oral inhalation only:
• Lung function test which shows a Forced Expiratory Volume in 1 second (FEV1) ≥ 90% of predicted value
• Ability to retro-breathe with nebulizer
• Height between 170 and 190 cm (extremes included)

You may not qualify if:

• Current smokers, or ex-smokers abstinent from tobacco for less than one year, or a history of smoking more than 10 packs a year
• Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14 days prior to dosing
• 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
• 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
• Malignancy, or prior malignancy, with a disease-free interval of \< 5 years after diagnosis and intervention, except basal cell carcinoma (treated curatively)
• Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis.
• History of hypersensitivity or allergies to any drug compound, including constituents of ALX-0171
• 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
• Receipt of any investigational drug within 60 days prior to dosing
• Intake of prescribed or over-the-counter medication within 14 days prior to dosing (≤ 3 g/day paracetamol is allowed)
• History or presence of alcohol or drug abuse
• Blood donation (\> 500 mL) or a comparable blood loss within three months prior to dosing
• Planned donation of germ cells, blood, organs, bone marrow during the course of the study or within 6 months thereafter
• Any other condition or prior therapy which, in the opinion of the Investigator, would make the subject unsuitable for this study
• Vulnerable subjects (e.g., persons kept in detention)

Sponsors & Collaborators

• Ablynx, a Sanofi company: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

gontivimab

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Steven De Bruyn, MD

  Ablynx NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 12, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

BE (1)