Single center, randomized, double-blind, 3-period, 3 treatments, 3 way crossover pharmacokinetics (PK)/pharmacodynamics (PD) trial to assess PK, PD, safety and tolerability of MYL-1401H after single subcutaneous injection at one dose level (2 mg) comparing to an EU and US marketed drug product (NEULASTA®) in healthy volunteers.

Single center, randomized, double-blind, 3-period, 3 treatments, 3 way crossover pharmacokinetics (PK)/pharmacodynamics (PD) trial to assess PK, PD, safety and tolerability of MYL-1401H after single subcutaneous injection at one dose level (2 mg) comparing to an EU and US marketed drug product (NEULASTA®) in healthy volunteers. - MYL-1401H bio-equivalency study to EU- and US marketed Neulasta®.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40799

Enrollment

216

Registered

2014-07-14

Start date

2014-08-26

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

Repeated single dose of 2 mg study drug delivered by 0.2 ml subcutaneous (SC) injections.

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 kg 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
Pharmacokinetics/Pharmacodynamics and safety; adverse events, laboratory data, vital signs, ECG and physical examination.	—

Secondary

Measure	Time frame
PD: general linear model (GLM) analyses of variance (ANOVA) on ANC AUC0-t, ANC Cmax, and ANC tmax and on CD34+ AUC0-t, CD34+ Cmax and CD34+ tmax; descriptive statistics PK: GLM ANOVA on AUC0-inf, Cmax, AUC0-t, tmax, kel, t1/2 and Vd/F; descriptive statistics	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)