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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT01483911
First received: November 30, 2011
Last updated: February 26, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
RSV Infection
Biological: ALX-0171
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Ablynx:

Primary Outcome Measures:
  • number of treatment-emergent adverse events [ Time Frame: until 1 month after last study drug administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • plasma concentration of ALX-0171 [ Time Frame: from predose until 5 days after study drug administration ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2011
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALX-0171 Biological: 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.
Placebo Comparator: Placebo Biological: Placebo
Single or multiple doses, administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483911

Locations
Netherlands
Groningen, Netherlands
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Josefin-Beate Holz, MD Ablynx
  More Information

No publications provided

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01483911     History of Changes
Other Study ID Numbers: ALX-0171-1.1/11
Study First Received: November 30, 2011
Last Updated: February 26, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Mononegavirales Infections
Paramyxoviridae Infections
Pneumovirus Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014