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

NCT01483911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-07-13

No results posted yet for this study

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.

Conditions

  • RSV Infection

Interventions

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.

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Josefin-Beate Holz, MD · Ablynx, a Sanofi company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01483911 on ClinicalTrials.gov