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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01483911

Enrollment

Registered

2011-12-02

Start date

2011-11-30

Completion date

2012-05-31

Last updated

2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RSV Infection

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.

Interventions

BIOLOGICALALX-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.

BIOLOGICALPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026