Clinical trial NCT06037395: Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Official title: A Randomized, Double-blind, Two-arm, Parallel Group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subject
Keywords: CT-P41
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 154
Sex: MALE
Minimum age (years): 28
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, Parallel group
Primary purpose: OTHER

Brief summary: A Randomized, Double-blind, Two-arm, Parallel group, Single-dose, Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety between CT-P41 and US-licensed Prolia in Healthy Male Subjects

Detailed description: This study was a randomized, double-blind, two-arm, parallel group, single-dose, phase I study designed to compare PK, PD, safety, and immunogenicity between CT-P41 and US-licensed Prolia in healthy male subjects. Subjects were randomized into a 1:1 ratio to receive a single dose (60 mg) of either CT-P41 or US-licensed Prolia. The subjects were followed up for 253 days.

Eligibility criteria: Inclusion Criteria:

1. Healthy male subject, between the ages of 28 and 55 years, both inclusive
2. Subject had a body mass index (BMI) between 18.5 and 29.9 kg/m2, both inclusive, and a body weight between 50.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
3. Subject with total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) and serum 25-OH vitamin D ≥ 20 ng/mL (≥ 50 nmol/L)

Exclusion Criteria:

1. Subject was a female.
2. Subject with a hypersensitivity to any component of denosumab or dry natural rubber (a derivative of latex).
3. Subject was confirmed or suspected with infection of coronavirus disease 2019 (COVID-19) at screening, or had had contact with COVID-19 patient within 14 days from screening.
4. Subject had a medical history of and/or current medical condition that can have effect on the study. Details to be discussed with investigator as per Protocol.

   1. Subjects with known risk factors for hypocalcaemia
   2. Subjects with known intolerance to calcium or vitamin D supplements
   3. Subjects with known infection with active hepatitis B, hepatitis C, human immunodeficiency virus, or syphilis
5. Subject had a history of and/or concurrent use of medications including any prior therapy that can have effect on the study. Details to be discussed with investigator as per Protocol.
6. Subjects have or had any therapy that might significantly affect bone metabolism

Primary outcomes:
measure: AUCinf
timeFrame: up to Day 253
measure: AUClast
timeFrame: up to Day 253
measure: Cmax
timeFrame: up to Day 253
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Bundang-gu
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Jung-gu
Study officials:
References: