First-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of NOX-H94

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2011
INTERVENTION: Intervention 1: Group A: healthy subjects will be included in a double blind, placebo controlled, single ascending IV dose design with NOX‐H94 (0,3 mg/kg). Intervention 2: Group B: healthy subjects will be included in a double blind, placebo controlled, single ascending IV dose design with NOX‐H94 (0,6 mg/kg). Intervention 3: Group C: healthy subjects will be included in a double blind, placebo controlled, single ascending IV dose design with NOX‐H94 (1,2 mg/kg). Intervention 4: Group D: healthy subjects will be included in a double blind, placebo controlled, single ascending IV dose design with NOX‐H94 (2,4 mg/kg). Intervention 5: Group E: healthy subjects will be included in a double blind, placebo controlled, single ascending IV dose design with NOX‐H94 (4,8 mg/kg). Intervention 6: Group F: 6 healthy male subjects are administered 8 subcutaneous doses of 36.5 mg NOX‐H94 in a randomized, double blind placebo‐controlled design. Intervention 7: Group G: 6 healthy male subjects are administered 5 intravenous doses of 0.6 mg/kg NOX‐H94 in a randomized, double blind placebo‐controlled design. Intervention 8: Group H: 6 healthy male subjects are administered 5 intravenous doses of 1.2 mg/kg NOX‐H94 in a randomized, double blind placebo controlled design. Intervention 9: Placebo: 5% Glucose Solution, 2 subjects in each of groups A to H CONDITION: D63 ‐ Anaemia in chronic diseases classified elsewhere PRIMARY OUTCOME: To determine the safety and tolerability of ascending single and multiple doses of NOX‐H94 in healthy subjects SECONDARY OUTCOME: 1) To determine the single and multiple dose pharmacokinetics of NOX‐H94 in healthy subjects and patients with anemia; 2)To assess the single and multiple dose pharmacodynamic response of NOX‐H94 in healthy subjects and patients with anemia INCLUSION CRITERIA: Groups A to G (healthy subjects): Healthy Male subjects or healthy female subjects of non‐childbearing potential (Groups A to E), healthy male subjects (groups F to H); Age 18‐65 years; Males willing to use 2 means of contraceptive methods for at least 2 months after the final examination
Epistemonikos ID: b6c0ebed6b819345ac12a04092f9cfc438cbf8b9
First added on: Aug 22, 2024