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Completed

NCT Number: NCT01483911

ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose 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.

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Key information

Conditions

RSV Infection Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALX-0171

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

Biological

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

Primary outcomes

  1. number of treatment-emergent adverse events

    Time frame: until 1 month after last study drug administration

Secondary outcomes

  1. plasma concentration of ALX-0171

    Time frame: from predose until 5 days after study drug administration

Sponsors and collaborators

Lead sponsor

Ablynx, a Sanofi company

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 2, 2011
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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