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

RSV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483911
• Other study ID #: ALX-0171-1.1/11
• Status: Completed
• Phase: Phase 1
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2018
• Source: Ablynx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ablynx

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of treatment-emergent adverse events		until 1 month after last study drug administration
Secondary	plasma concentration of ALX-0171		from predose until 5 days after study drug administration