| CTRI Number |
CTRI/2019/01/017346 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
19/12/2019 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative pharmacokinetic study of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection in healthy adult human subjects. |
|
Scientific Title of Study
|
A randomized, double-blind, parallel, single dose comparative pharmacokinetic study of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection in healthy adult human subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BA1786163 Version 2 dated,29 November 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Minesh Patel |
| Designation |
MBBS |
| Affiliation |
Cliantha Research Limited |
| Address |
Sigma-1 Corporate,
B/H. Rajpath Club,
Opposite Mann Party Plot,
Off. S.G Highway, Bodakdev,
Ahmedabad-380 054,
Gujarat, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
079-66135601 |
| Fax |
|
| Email |
mnpatel@cliantha.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Taufik Momin |
| Designation |
Principal Scientist |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad-382213 Gujarat
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717-665555 |
| Fax |
|
| Email |
Taufik.Momin@zyduscadila.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Taufik Momin |
| Designation |
Principal Scientist |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad-382213 Gujarat
Ahmadabad
GUJARAT
382213
India |
| Phone |
02717-665555 |
| Fax |
|
| Email |
Taufik.Momin@zyduscadila.com |
|
|
Source of Monetary or Material Support
|
|
Source of Monetary or Material Support
Cadila Healthcare Ltd. Zydus Tower Satellite Cross Road, Ahmedabad 380015 Gujarat, India |
|
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Primary Sponsor
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Research Centre |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minesh Patel |
Zydus Hospital |
Zydus Hospital Road,Nr.Sola Bridge, S.G.Highway.
Ahmadabad
GUJARAT |
079-66135601
mpatel@cliantha.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medilink Ethics committee,Near Shyaml cross road,Ahmedabad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HUMIRA® Adalimumab |
Injection (40 mg) |
| Intervention |
Zydus Adalimumab |
Injection (40 mg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)BMI:18.5 to 30.0 weight in kg/(height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
2)Volunteer having body weight between 50 to 85 Kg (both inclusive).
3)Non-smokers and non-tobacco users (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
4)Able to communicate effectively with study personnel.
5)Able to give written informed consent to participate in the study.
6)Able to signed and dated written informed consent prior to any study-specific procedures, Willing and able to comply with the study procedures, restrictions and requirements.
7)Volunteers who are negative for drugs of abuse and alcohol breath tests at screening.
8)Male Volunteers should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child during the course of the study and 03 months after administration of study medication. |
|
| ExclusionCriteria |
| Details |
1)History of allergic responses/exposure to Adalimumab or HUMIRA or other related drugs, or antibodies.
2)Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along (for female volunteers)].
3)Any disease or condition like diabetes, psychosis or others which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
4)History or presence of bronchial asthma.
5)Use of any hormone replacement therapy within 3 months prior to the study medication.
6)A depot injection or implant of any drug within 3 months prior to the study medication.
7)Use of enzyme-modifying drugs within 30 days prior to the study medication.
8)History of drug dependence or of alcoholism or of moderate alcohol use
9)History of difficulty with donating blood or difficulty in accessibility of veins.
10)A positive hepatitis screen (includes subtypes B & C).
11)A positive test result for HIV antibody and / or syphilis (RPR/VDRL). |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Pharmacokinetics similarity of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection after administration of subcutaneous single dose in adult healthy human subjects. |
pre-dose (0.0 hour) and at 0.333, 1.0, 4.0, 8.0, 12.0, 24.0, 48.0, 72.0, 96.0, 120.0, 144.0, 168.0, 192.0, 216.0, 264.0, 336.0, 384.0, 528.0, 696.0, 864.0, 1032.0, 1200.0, 1320.0, 1512.0 and 1704.0 hours post-dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To evaluate the potential immunogenicity of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection in adult healthy human subjects.
•To assess and compare the safety and tolerability of Zydus Adalimumab (ZRC-3197) Injection and HUMIRA® Adalimumab Injection in adult healthy human subjects.
|
pre-dose (0.0 hour) and at 384.0, 696.0 and 1704.0 hours post-dose |
|
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Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="154" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
05/02/2019 |
| Date of Study Completion (India) |
11/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a randomized, double-blind, single dose, two-arm, parallel
study to compare the pharmacokinetics (PK), immunogenicity and safety of two
preparations of Adalimumab namely - Zydus Adalimumab (ZRC-3197) Injection
and HUMIRA® Adalimumab Injection.
|