Single centre, randomised, open-label, 2-dose, parallel trial to compare immunogenicity, safety, tolerability, and pharmacodynamics of MYL-1401H and US-licensed Pegfilgastrim (NEULASTA®) after two subcutaneous (SC) injections at one dose level (6 MG) in healthy subjects.

Single centre, randomised, open-label, 2-dose, parallel trial to compare immunogenicity, safety, tolerability, and pharmacodynamics of MYL-1401H and US-licensed Pegfilgastrim (NEULASTA®) after two subcutaneous (SC) injections at one dose level (6 MG) in healthy subjects. - MYL-1401H Immunogenicity comparability trial to US-Neulasta®

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42699

Enrollment

Registered

2015-07-29

Start date

2015-07-29

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Neutropenia

Interventions

Each period a dosage of 0.6 mL MYL-1401H or Neulasta® US by subcutane (SC) injection.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female subjects 18 - 65 years of age, inclusive BMI 19.0 - 30.0 kilograms/meter2 weight at least 60.0 kilograms non-smoking or smoke maximally 5 cigarettes per day

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 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 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Immunogenicity/safety/tolerability/pharmacodynamics; side effects, lab data, vital signs, ECG and physical examination.	—

Secondary

Measure	Time frame
Immunogenicity: Serum ADA concentrations Pharmacodynamics : Absolute neutrophil count (ANC) in periods 1 and 2: area under the effective concentration-time curve (AUEC) and ANCmax and derived PD parameters (AUEC0-t, Cmax and tmax)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)