A Study of HM10760A (Long-acting Erythropoietin (EPO)) in Healthy Korean Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: HM10760A or Placebo
- Registration Number
- NCT01013064
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
Study design:
* Randomized, double-blind, placebo-controlled, sequential dose escalation
* Six ascending dose cohorts are planned
Primary Objective:
* To evaluate the safety profile of single escalating intravenous dose levels of HM10760A
- Detailed Description
Secondary objectives:
* To evaluate the dose response relationship of a single IV dose of HM10760A on pharmacodynamic parameters including hemoglobin, reticulocyte count, and reticulocyte hemoglobin content
* To evaluate the pharmacokinetic profiles of single IV dose levels of HM10760A
* To determine the pharmacologically active dose(PAD) of HM10760A
* To assess the immunogenicity of a single IV dose of HM10760A
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 48
Inclusion Criteria
- Age 20 to 55 years
- Able and willing to provided written informed consent
- Hemoglobin < 16 g/dL
Exclusion Criteria
- Prior exposure to EPO, darbepoetin, other EPO support proteins
- hypersensitivity to EPO, darbepoetin, E.coli derived proteins
- Hemoglobinopathy
- SBP > 140 mmHg or < 90 mmHg or DBP > 95 mmHg
- Chronic, uncontrolled, or symptomatic inflammatory disease
- Malignancy(except non-melanoma skin cancer)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort5 HM10760A or Placebo - Cohort6 HM10760A or Placebo - Cohort1 HM10760A or Placebo - Cohort2 HM10760A or Placebo - Cohort3 HM10760A or Placebo - Cohort4 HM10760A or Placebo -
- Primary Outcome Measures
Name Time Method Safety data, including physical examinations, laboratory evaluation, ECGs, vital signs, adverse events, and immunogenicity 84 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hanmi Clinical
🇰🇷Seoul, Korea, Republic of