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

Phase 1

Completed

• Conditions: RSV Infection
• Interventions: Biological: Placebo; Biological: ALX-0171

• Registration Number: NCT01483911
• Lead Sponsor: Ablynx, a Sanofi company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ALX-0171	ALX-0171	-

Primary Outcome Measures

Name	Time	Method
number of treatment-emergent adverse events	until 1 month after last study drug administration

Secondary Outcome Measures

Name	Time	Method
plasma concentration of ALX-0171	from predose until 5 days after study drug administration