OX-A12 to Mobilize Stem Cells in Healthy Volunteers - A Single-center, Single Dose, Open Label, Dose Escalation Study of Intravenous NOX-A12 in up to 42 Healthy Subjects

Phase 1

• Conditions: C82; C83; C90.0; Autologous Stem Cell Transplantation; Follicular lymphoma; Non-follicular lymphoma; Multiple myeloma

• Registration Number: DRKS00000223
• Lead Sponsor: OXXON Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-25
• Study Completion: 2010-04-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Healthy male and female subjects willing to use appropriate contraception methods
- Body mass index 19 - 29 kg/m2 (extremes included)
- Body weight between 50 and 100 kg (extremes included)
- Calculated creatinine clearance >80 mL/min
- Normal lung function (FVC and FEV1 at least 80% of predicted values)

Exclusion Criteria

- Abnormal spleen size
- History of thrombosis
- Intake of any prescribed systemic or topical medication within 14 days prior to dosing
- History of relevant heart disorders or evidence of hyper- or hypotension (sitting blood pressure systolic >140 mmHg or <95 mmHg or diastolic >90 mmHg or <65 mmHg)
- Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, hematological or other significant acute or chronic abnormalities which might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the active agent under investigation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of NOX-A12 by means of adverse events, vital signs, laboratory parameters, 12-lead ECG and immunogenicity assessment at regular intervals throughout the entire study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters in plasma and urine at regular intervals throughout the entire study || Pharmacodynamic parameters (CFU and CD34 positve leucocytes) at regular intervals throughout the entire study