CTRI/2023/04/051487招募中1 期
An open label, randomized, three dose, parallel, safety, pharmacokinetic, pharmacodynamic and immunogenicity assessment study of Navalbumin(Recombinant Human albumin) with Human Albumin in healthy adult humansubjects.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •9) No history of addiction to any recreational drug or drug dependence or alcohol
- •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).
排除标准
- •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
研究者
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