CTRI/2023/04/051487 [Registered on: 11/04/2023] Trial Registered Prospectively
Last Modified On:
12/05/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A phase-I, open label, randomized, three dose, parallel, safety, pharmacokinetic,
pharmacodynamic and immunogenicity assessment study.
Scientific Title of Study
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 human
subjects.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
C1B01642, Version No. 05, Dated 29 July 2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Praveen Kumar Garg
Designation
Principal Investigator
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited
Cliantha Corporate,
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India Cliantha Corporate,
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India Ahmadabad GUJARAT 382210 India
Phone
91-9825155017
Fax
Email
praveen_k_garg@yahoo.com
Details of Contact Person Scientific Query
Name
Dr Praveen Kumar Garg
Designation
Principal Investigator
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited
Cliantha Corporate,
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India Cliantha Corporate,
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India Ahmadabad GUJARAT 382210 India
Phone
91-9825155017
Fax
Email
praveen_k_garg@yahoo.com
Details of Contact Person Public Query
Name
P Veerendra Kumar
Designation
Head – Clinical Affairs Division
Affiliation
Shilpa Biologicals Private Limited (Formerly Known as Shilpa Medicare Limited)
Address
Shilpa Medicare Limited Unit VII- IDA- Mallapur- Nacharam
Hyderabad
TELANGANA
500076
India Plot No: 532 (A), KIADB, Belur Industrial Area,
Dharwad – 580 011, Karnataka, India Medchal TELANGANA 500076 India
Phone
91-9177033911
Fax
Email
veerendrap.frd@shilpamedicare.com
Source of Monetary or Material Support
Shilpa Biologicals Private Limited, (Formerly Known as Shilpa Medicare Limited),
Plot No: 532 (A), KIADB, Belur Industrial Area,
Dharwad – 580 011, Karnataka, India
Primary Sponsor
Name
Shilpa Biologicals Private Limited
Address
Shilpa Biologicals Private Limited, (Formerly Known as Shilpa Medicare Limited), Plot No: 532 (A), KIADB, Belur Industrial Area, Dharwad – 580 011, Karnataka, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Praveen Kumar Garg
Cliantha Research Limited
Cliantha Research Limited
Cliantha Corporate,
TP 86, FP 28/1,
Off S.P. Ring Road, Sarkhej,
Ahmedabad-382210,
Gujarat, India Ahmadabad GUJARAT
9825155017
praveen_k_garg@yahoo.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Sangini Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy Human Volunteers
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
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 dose level 3: 40 g (Cohort-3).
Part 2: subjects will receive three consecutive doses of the assigned investigational product by intravenous infusion via infusion pump at 3-week intervals at a rate of 2 mL/min, i.e., Dose 1- 10 g (50 mL) on day 1, Dose 2- 20 g (100 mL) on day 22 and Dose 3- 40 g (200 mL) on day 43. Maximum 70 g of the investigational product will be infused during the study period
Route of Administration: Intravenous infusion via infusion pump
Total Duration: 95 days
Intervention
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
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).
ExclusionCriteria
Details
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 medication (including over-the-counter products),
and recreational drugs such as marijuana, amphetamine, barbiturates, cocaine,
benzodiazepines and morphine 14 days prior to housing or subject who is not
ready to abstain them till last study related procedure. This includes vitamins taken
as nutritional supplements for non-therapeutic indication.
22) Subjects who is not ready to abstain from any prescription medicine or Over the
Counter (OTC) products (including vitamins and products from natural origin e.g.
St. John’s Wort) during the course of the study.
23) Subjects who have undergone or planning to undergo hormone replacement
therapy and are not ready to abstain from the use of androgens or anabolic steroids
during the study.
24) Subject who is not ready to abstain from participation in any other clinical study
during this study and within 90 days or more as per investigator’s instruction after
completion of the study.
Method of Generating Random Sequence
Other
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Part 1:
• To establish safety and tolerability of the test product up to 40g
• To determine the maximum tolerated dose (MTD)
• To support the administration of the recommended dose for Part 2 of
the study in healthy subjects
• To evaluate the immunogenicity of Navalbumin.
Part 2:
To evaluate the pharmacokinetics of Navalbumin as compared to Human Albumin in healthy adult human subjects
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 Outcome
Outcome
TimePoints
• To evaluate the pharmacodynamics and immunogenicity of Shilpa Recombinant Human Albumin as compared to Human Albumin.
• To assess the safety and tolerability of the investigational products
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
Target Sample Size
Total Sample Size="68" Sample Size from India="68" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a phase-I open label, randomized, three dose, parallel, safety, pharmacokinetic, pharmacodynamic and immunogenicity assessment study of Navalbumin (Recombinant Human albumin) with Human Albumin in healthy adult human subjects.
Objectives:
Part 1:
• To establish safety and tolerability of the test product up to 40g
• To determine the maximum tolerated dose (MTD)
• To support the administration of the recommended dose for Part 2 of the study in healthy subjects
• To evaluate the immunogenicity of Navalbumin.
Part 2:
Primary objective:
• To evaluate the pharmacokinetics of Navalbumin as compared to Human Albumin in healthy adult human subjects
Secondary objective:
• To evaluate the pharmacodynamics and immunogenicity of Navalbumin as compared to Human Albumin.
• To assess the safety and tolerability of the investigational products