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

A phase 1 double blind, placebo controlled study of ALX-0141 single dose subcutaneous administration in healthy post-menopausal women - ALX-0141 s.c. SAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32748

Enrollment

Registered

2009-11-18

Start date

2009-12-11

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Bone loss

Interventions

Study Medication: Active substance : ALX-0141 Activity : anti-RANKL Indication : bone loss Strength : 65 mg/mL Dosage form : s.c. injection Treatments : Cohort 1: a single s.c. dose of 0.003 mg/kg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)