CTRI/2025/09/094935 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On:
25/09/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
This is a study to assess the Safety, tolerability and pharmacokinetics of single and multiple ascending dose of MKP 11093 suspension administered orally in healthy subjects
Scientific Title of Study
A Phase 1, Double-blind, Randomized, Placebo controlled study, to assess the Safety, tolerability and pharmacokinetics of single and multiple ascending dose of MKP 11093 suspension administered orally in healthy subjects
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No: 0233-24, Version: 2.0, Dated: 25 February 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Shrikrishna Kolte
Designation
General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S. G. Highway, Gota, India
Mankind Research Center (a unit of Mankind Pharma Limited)
Address
Mankind Research Center (a unit of Mankind Pharma Limited)
191-E, Sector 4-II, IMT Manesar, Gurugram,
Haryana. India – 122050
Gurgaon HARYANA 122050 India
Phone
911242873900
Fax
911242873900
Email
santosh.rai@mankindpharma.com
Source of Monetary or Material Support
Mankind Pharma Limited, 208, Okhla Industrial Estate, Phase III, New Delhi 110020
Primary Sponsor
Name
Mankind Pharma Limited
Address
208, Okhla Industrial Estate, Phase III, New Delhi 110020
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NA
NA
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Shrikrishna Kolte
Lambda Therapeutic Research Ltd
Lambda house, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota, GUJARAT
Ahmadabad GUJARAT
07940202260
shrikrishnaskolte@lambda-cro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Riddhi Medical nursing Home IEC
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Placebo-P: Identical formulation without active ingredient
Placebo-P: Identical formulation without active ingredient
Intervention
Test Product-T: MKP11093 Suspension 25mg, 50mg, 100mg, 150mg, 200mg, and 300mg (SAD) and 25mg, 50mg, 75mg, 100mg and 150mg, (MAD)
Dose: 25mg, 50mg, 100mg, 150mg, 200mg, and 300mg (SAD) and 25mg, 50mg, 75mg, 100mg and 150mg, (MAD)
Route of administration: Oral administration
Frequency: Single dose
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
a) Non-smoker, normal, healthy adult male human volunteers between 18 to 45 years of age (both
inclusive).
b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in
kg per height in meter2.
c) Volunteer should be literate
d) Not having any significant disease in medical history or clinically significant abnormal findings
during screening, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest
(P/A view) recordings.
e) Able to understand and comply with the study procedures, in the opinion of the principal
investigator.
f) Able to give voluntary written informed consent for participation in the trial.
ExclusionCriteria
Details
a) Known hypersensitivity or idiosyncratic reaction to normally used medicines such as antihistamines,
NSAIDs or any of the excipients or related drug.
b) History or presence of any disease or condition which might compromise the haemopoietic, renal,
hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,
gastrointestinal or any other body system.
c) Ingestion of a medicine (CYP inducers or inhibitors including herbal medicines) at any time
within 14 days prior to dosing of part 1/first IMP administration of part 2 and Any vaccine
(including COVID-19 vaccine) within 14 days prior to dosing of part 1/ Prior to first dosing in
Part 2. In any such case subject selection will be at the discretion of the Principal Investigator.
d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs
induced urticaria.
e) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug
scans.
f) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more
than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 mL of
wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of
alcohol or alcoholic products within 48 hours prior to dosing of part 1/first IMP administration of
part 2.
g) Smokers, or who have smoked within last six months prior to start of the study.
h) The presence of clinically significant abnormal laboratory values including D-Dimer, APTT and
PT during screening.
i) The presence of clinically significant abnormal laboratory values during screening.
j) History or presence of seizure or psychiatric disorders.
k) A history of difficulty in donating blood.
l) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
m) Receipt of an investigational medicinal product or participation in a drug research study within a
period of 90 days prior to the first dose of study medication. If investigational medicinal product is received within 90 days where there is no blood loss
except safety lab testing, subject can be included considering 10 half-lives duration of
investigational medicinal product received.
n) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
o) A positive test result for HIV (1 and/or 2) antibody.
p) Consumption of Grapefruits or Grapefruit products within 72 hours prior to dosing of part 1/first
IMP administration of part 2.
q) A Positive test results for IGRA (Interferon-Gamma Release Assays) (for Tuberculosis) at
screening.
r) An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for
four weeks prior to dosing of part 1/first IMP administration of part 2. In any such case subject
selection will be at the discretion of the Principal Investigator.
s) History of, or evidence of, active or latent tuberculosis; had a history of diabetes or
lymphoproliferative disease or evidence of immunosuppression.
t) Subjects on steroids or any anti-inflammatory drugs.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Single Ascending Dose (SAD)-To evaluate the safety and tolerability of the Different dose levels of MKP 11093 after single-dose administration
Multiple Ascending Dose (MAD)-To evaluate the safety and tolerability of the Different dose levels of MKP 11093 after multiple-dose administration
SAD study - pre dose (0.000) and at 0.500, 1.000, 2.000, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 18.000, 24.000, 48.000 and 72.000 hours post dose.
MAD study-Pre-dose samples: (Total 6 samples) (Morning dose) On Day 01, Day 05, Day 06, Day 07, Day 13 and Day 14 prior to dosing
Post-dose sample (Morning dose) (Day 01) (Total 20 samples) The venous blood samples will be withdrawn at 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 3.500, 4.000, 5.000, 6.000, ,8.000, 10.000, 12.000, 12.500, 13.000, 13.500, 14.000, 16.000, 20.000 and 24.000 hours
Post-dose sample (Morning dose) (Day 14) (Total 21 samples) The venous blood samples will be withdrawn at 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, ,8.000, 10.000, 12.000, 12.500, 13.000, 13.500, 14.000, 16.000, 20.000, 24.000, 48.000 and 72.000
Secondary Outcome
Outcome
TimePoints
Single Ascending Dose (SAD)-To characterize the single-dose pharmacokinetic profiles of MKP 11093 in human subjects and to evaluate the Dose proportionality after single dose.
Multiple Ascending Dose (MAD)- To characterize the multiple-dose pharmacokinetic profiles of MKP 11093 in human subjects and To evaluate the Dose proportionality after multiple dose
SAD study - pre dose (0.000) and at 0.500, 1.000, 2.000, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000,
12.000, 18.000, 24.000, 48.000 and 72.000 hours post dose.
MAD study-Pre-dose samples: (Total 6 samples) (Morning dose) On Day 01, Day 05, Day 06, Day 07, Day 13 and Day 14 prior to dosing
Post-dose sample (Morning dose) (Day 01) (Total 20 samples) The venous blood samples will be withdrawn at 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 3.500, 4.000, 5.000, 6.000, ,8.000, 10.000, 12.000, 12.500, 13.000, 13.500, 14.000, 16.000, 20.000 and 24.000 hours
Post-dose sample (Morning dose) (Day 14) (Total 21 samples)
The venous blood samples will be withdrawn at 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, ,8.000, 10.000, 12.000, 12.500, 13.000, 13.500, 14.000, 16.000, 20.000, 24.000, 48.000 and 72.000
Target Sample Size
Total Sample Size="88" Sample Size from India="88" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 1
Date of First Enrollment (India)
23/09/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Primary Objective is to evaluate the safety and tolerability of the Different dose levels of MKP 11093 after single-dose administration and Secondary Objective is to characterize the single-dose pharmacokinetic profiles of MKP 11093 in human subjects and To evaluate the Dose proportionality after single dose.