A phase 1 double blind, placebo controlled study of ALX-0141 single dose subcutaneous administration in healthy post-menopausal wome

Completed

• Conditions: Bone loss; 10005959

• Registration Number: NL-OMON32748
• Lead Sponsor: Ablynx N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

Healthy post menopausal women, 18 - 80 years old, BMI between 18 and 36 kg/m2, moderate or non-smoker.

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.0 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics:<br /><br>P1NP, CTX-1, BAP and TRACP5b concentrations in serum and creatinin, CTX-1& and<br /><br>NTX 1 concentrations in urine.<br /><br><br /><br>Pharmacokinetics:<br /><br>Plasma ALX-0141 concentrations, pharmacokinetic parameters.<br /><br><br /><br>Safety:<br /><br>AEs, local tolerability, vital signs, 12-lead ECG, clinical laboratory,<br /><br>physical examination, immunogenicity, 25-hydroxy vitamin D in serum,<br /><br>immunophenotyping of WBC.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>