Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers

NCT03822884 | Completed Phase 1 Results

• 1 other identifier: HMX.1.003
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pharmacokinetic/Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers SPONSOR Biosidus S.A.

Conditions

Anemia

Outcome Measures

Primary Outcomes (4)

• AUC0-t

  AUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours).

  120 h

• AUC0-∞

  AUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞.

  120hr

• Cmax

  Cmax: maximum serum concentration of epoetin alfa.

  120hr

• Tmax

  Tmax: time to the maximum serum concentration of epoetin alfa

  120hr

Secondary Outcomes (4)

• Reticulocyte Response: Cmax

  120hr

• Reticulocyte Response: AUC 0-120h

  120hr

• ADAs

  120hr

• Adverse Events

  120hr

Study Arms (3)

Hemax® PFS 40,000 UI

EXPERIMENTAL

Epoetin Alfa 40000 UNT/ML subcutaneous single dose

Drug: Epoetin Alfa 40000 UNT/ML

Hemax® 40,000 UI

EXPERIMENTAL

Epoetin Alfa 40000 UNT/ML subcutaneous single dose

Drug: Epoetin Alfa 40000 UNT/ML

Erypo ® 40,000 UI

ACTIVE COMPARATOR

Epoetin Alfa 40000 UNT/ML subcutaneous single dose

Drug: Epoetin Alfa 40000 UNT/ML

Interventions

Epoetin Alfa 40000 UNT/ML DRUG

40.000 UI subcutaneous single dose

Also known as: Hemax, Hemax PFS, Erypo

Erypo ® 40,000 UI; Hemax® 40,000 UI; Hemax® PFS 40,000 UI

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects of both sexes aged 21 - 55 years old.
• Baseline Hb levels between 11 and 14 in women and between 12 and 15 g/ dl in men.
• Body Mass Index (BMI) between 19 and 27 kg/ m2.
• Subjects with systolic blood pressure higher than 100 mm Hg and lower than 139 mm Hg, diastolic blood pressure higher than 70 mm Hg and lower than 89 mm H, heart rate higher than 50 and lower than 90 heartbeats per minute after 5 minutes in sitting position and then in standing position (extreme values included).
• Volunteers who are well disposed to the study and have signed the approved informed consent before the beginning of the study.

You may not qualify if:

• History of clinically significant allergies (except untreated asymptomatic seasonal allergies).
• Decrease of more than 20 mm Hg in systolic blood pressure or more than 10 mm Hg in diastolic blood pressure within the first 3 minutes after the change in body position.
• Volunteers who are or have been taking other drugs (prescription or over - the - counter) within two weeks before the study.
• Volunteers with a history of autoimmune diseases.
• Organic CNS, psychological, or psychiatric disorders: epilepsy, manic - depressive tendencies, serious depressive episodes, insomnia, changes in personality.
• Active infections.
• Allergic to epoetin alfa or related substances, to human albumin, or any of the ingredients of the formulations.
• Previous exposure to recombinant epoetin.
• Active smoker (more than 10 cigarettes/ day).
• Current clinical evidence of severe digestive disorders.
• Current clinical evidence of kidney diseases.
• Current evidence of liver disorders.
• Current clinical evidence of respiratory or heart diseases.
• Diabetes mellitus, thyroid dysfunction, or other endocrine disorders.
• Evidence of active gastroduodenal disease.

Sponsors & Collaborators

• Bio Sidus SA: lead

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Clinical Trial Manager - Dr. Roberto A. Diez
• Organization: Biosidus S.A.

r.diez@biosidus.com.ar

+5411 4909 8000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: January 30, 2019
• Study Start: September 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 12, 2020
• Results First Posted: February 12, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share