A phase-I, open label, randomized, three dose, parallel, safety, pharmacokinetic,pharmacodynamic and immunogenicity assessment study.
- Registration Number
- CTRI/2023/04/051487
- Lead Sponsor
- Shilpa Biologicals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method