None listed
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Human Albumin 200 g/l: Dose and Frequency:
Part 1: 3 cohorts, starting dose level 1: 10 g (Cohort-1), followed by dose level 2: 20 g (Cohort-2) and then
Sponsors
Shilpa Biologicals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Gender: Male (for part 1) and Male and/or non-pregnant, non-lactating female (for part 2) who are willing to provide voluntary informed consent for participation in study and to follow the protocol requirements. 2) Normal healthy adult human subjects between 18-45 years (both inclusive) of age. 3) Body mass index of 18.5 to 30.0 kg/m2 (both inclusive); BMI value should be rounded off to one significant digit after decimal point (e.g. 29.04 rounds down to 29.0, while 18.45 rounds up to 18.5). 4) No evidence of any other underlying disease during the screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest Xray recording, for part 2 gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)]. 5) Screening laboratory tests are either normal or within acceptable limits or are considered by the principal or sub-investigator or physician to be of no clinical significance with respect to participation in the study. 6) Normal chest X-ray taken within 11 months before the day of dosing initiation. 7) 12-lead ECG recording within normal or within acceptable limits or are of no clinical significance with respect to his participation in the study as confirmed by the principal or sub-investigator or physician. 8) Volunteers who are ready to be available for the entire study period and are capable of understanding and communicating with the investigator and clinical study facility staff. 9) No history of addiction to any recreational drug or drug dependence or alcohol addiction. 10) Female subject must have used an acceptable method of contraception during intercourse at least 48.0 hours prior to housing, and must agree to use during the study & for 07 days after study completion (for part 2).
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity or contraindication to human plasma proteins or to any of the components of investigational product or to any of the related products. 2) History of allergic reaction to Pichia Pastoris, S. Cerevisiae or Yeast products. 3) Subjects who had received systemic treatment with corticosteroids or human plasma derivatives within 04 weeks prior to the first dose of study medication. 4) History or presence of any other significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 5) History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products. 6) History/presence of significant asthma, urticaria or other allergic type reactions after taking any medication. 7) History/presence of any other clinically significant illness within 04 weeks prior to the first dose of study medication. 8) Volunteers who have scheduled for surgery any time during study or at least within 20 days after study completion. 9) History of difficulty in donating blood. 10) Volunteers who have unsuitable veins for repeated vein puncture. 11) Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater. 12) Evidence of skin lesions on forearm or signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial. 13) Volunteers who have participated in a clinical drug study or bioequivalence study within 90 days prior to the first dose of study medication or subjects who have not completed sufficient days of participation in clinical study as indicated by the investigator/ institute of the last study participation as reflected in OVIS. 14) Volunteers who have taken any other prescription medication or OTC products (including vitamins and natural products) within 14 days prior to housing, including topical medication. 15) Volunteers with positive serology for Hepatitis B Virus (HbsAg), Hepatitis C Virus (Anti HCV), Human Immunodeficiency Virus (HIV), or Syphilis (RPR). 16) Volunteers with positive urine screen for drugs of abuse during screening and before check-in. 17) Volunteers with positive alcohol test during screening and before check-in. 18) Female volunteers with positive serum pregnancy test during screening or urine pregnancy test before check-in (for part 2). 19) Volunteers who have consumed tobacco containing products (smoking, tobacco chewing, gutkha etc.) and xanthine containing food and beverages, (chocolates, tea, coffee or cola drinks) for at least 48.0 hours prior to housing or volunteer who is not ready to abstain from them till last study related procedure. 20) Volunteers who have consumed alcohol, grapefruit or its juice and cranberry juice for at least 48.0 hours prior to housing or subject who is not ready to abstain from them till last study related procedure. 21) Volunteers who have taken any medic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: â?¢ To establish safety and tolerability of the test product up to 40g â?¢ To determine the maximum tolerated dose (MTD) â?¢ To support the administration of the recommended dose for Part 2 of the study in healthy subjects â?¢ To evaluate the immunogenicity of Navalbumin. Part 2: To evaluate the pharmacokinetics of Navalbumin as compared to Human Albumin in healthy adult human subjectsTimepoint: Pharmacokinetic Blood sampling: On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate the pharmacodynamics and immunogenicity of Shilpa Recombinant Human Albumin as compared to Human Albumin. â?¢ To assess the safety and tolerability of the investigational productsTimepoint: Blood samples for Colloid Osmotic Pressure and For Hematocrit ratio: On day 1: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours On day 22: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0 and 192.0 hours On day 43: 0.083, 0.25, 0.5, 1.0, 2.0, 6.0, 12.0, 24.0, 72.0, 144.0, 192.0, 360.0, 528.0, 768.0 and 1152.0 hours | — |
Countries
India
Contacts
Public ContactP Veerendra Kumar
Cliantha Research Limited
Outcome results
None listed