CTRI/2022/02/039885 [Registered on: 01/02/2022] Trial Registered Prospectively
Last Modified On:
31/01/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
To Evaluate Safety, Tolerability and
Pharmacokinetics of AB1001 Topical Gel in Healthy Adult Male Volunteers
Scientific Title of Study
Phase-I, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability and
Pharmacokinetics of AB1001 Topical Gel in Healthy Adult Male Volunteers
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
21-VIN-0116 ( AH-AB1001-01) Version 01 dated 19th May 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Kiran Marthak
Designation
PRINCIPAL INVESTIGATOR
Affiliation
Veeda Clinical Research Pvt. Ltd.
Address
Veeda Clinical Research Pvt. Ltd.
1st, 2nd, 3rd and 4th Floor
VEDANT Complex, Nr. Y.M.C.A. Club,
S.G.Highway Road, Vejalpur,
Ahmedabad, Gujarat, India 1st, 2nd, 3rd and 4th Floor
VEDANT Complex, Nr. Y.M.C.A. Club,S.G.Highway Road, Vejalpur,
Ahmedabad, Gujarat, India Ahmadabad GUJARAT 380 051 India
Phone
07967773000
Fax
079-30013010
Email
Kiran.Marthak@veedacr.com
Details of Contact Person Scientific Query
Name
Dr Kiran Marthak
Designation
PRINCIPAL INVESTIGATOR
Affiliation
Veeda Clinical Research Pvt. Ltd.
Address
Veeda Clinical Research Pvt. Ltd.
1st, 2nd, 3rd and 4th Floor
VEDANT Complex, Nr. Y.M.C.A. Club,
S.G.Highway Road, Vejalpur,
Ahmedabad, Gujarat, India 1st, 2nd, 3rd and 4th Floor
VEDANT Complex, Nr. Y.M.C.A. Club,S.G.Highway Road, Vejalpur,
Ahmedabad, Gujarat, India
GUJARAT 380 051 India
Phone
07967773000
Fax
079-30013010
Email
Kiran.Marthak@veedacr.com
Details of Contact Person Public Query
Name
Dr Kiran Marthak
Designation
PRINCIPAL INVESTIGATOR
Affiliation
Veeda Clinical Research Pvt. Ltd.
Address
Veeda Clinical Research Pvt. Ltd.
1st, 2nd, 3rd and 4th Floor
VEDANT Complex, Nr. Y.M.C.A. Club,
S.G.Highway Road, Vejalpur,
Ahmedabad, Gujarat, India 1st, 2nd, 3rd and 4th Floor
VEDANT Complex, Nr. Y.M.C.A. Club,S.G.Highway Road, Vejalpur,
Ahmedabad, Gujarat, India
GUJARAT 380 051 India
Phone
07967773000
Fax
079-30013010
Email
Kiran.Marthak@veedacr.com
Source of Monetary or Material Support
Veeda Clinical Research Pvt. Ltd. 1st, 2nd, 3rd and 4th Floor VEDANT Complex, Nr. Y.M.C.A.
Club, S.G.Highway Road, Vejalpur, Ahmedabad 380 051, Gujarat, India
Primary Sponsor
Name
AHAMMUNE BIOSCIENCES PRIVATE LIMITED
Address
300, NCL INNOVATION PARK,
DR HOMI BHABHA ROAD, PUNE
411008 MAHARASHTRA, INDIA
Healthy, willing, adult male volunteers of age between 18 and 45
years (both inclusive), with Body Mass Index (18.50 to 30.00 kg/m2
(both inclusive) and minimum of 45 kg weight.
Intervention / Comparator Agent
Type
Name
Details
Intervention
AB1001 Topical Gel
AB1001 Topical Gel of Ahammune
Biosciences Private Limited - Duration of Therapy 15 days
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Male
Details
1. Male subjects, aged ≥18 years and ≤ 45 years, with a confirmed healthy
status as per standard screening procedure for healthy volunteers at the
screening center.
2. Subject is in good general health and free of any known uncontrolled
disease state or physical condition which, in the opinion of the investigator,
would interfere with the study assessments or put the subject at undue risk
by study participation.
3. Subjects must be willing and able to comply with the conditions specified in
this protocol and study procedures in the opinion of the Investigator.
4. Subjects must provide audio-visual and written informed consent prior to
any study-specific procedure.
5. Should have reliable access to the clinical trial center and available in the
area for at least one month.
ExclusionCriteria
Details
1. Hemoglobin, white blood cell (WBC), platelets, alanine transaminase
(ALT), and creatinine (Cr) outside of local lab normal range (subjects
may be included at the investigator’s discretion for not clinically
significant values outside of normal range).
2. Subjects with a clinically significant abnormal thyroid-stimulating
hormone (TSH) or free T4 at screening.
3. Abnormal urinalysis as defined by positive urine glucose, protein, and
hemoglobin. Subject can be included if investigator determine the
abnormality is not clinically significant.
4. Use of any Investigational vaccine within the last five years except for
Covid-19 vaccines.
5. Chronic systemic immunosuppressive medications
6. Recurrent receipt of blood products or immunoglobulins.
7. Clinically significant medical condition, physical examination findings,
other clinically significant abnormal laboratory results, or past medical
history that may have clinically significant implications for current
health status and participation in the study in the opinion of the
Investigator.
8. Any contraindication to repeated phlebotomy.
9. History of or known active cardiac disease.
10. Infection with HIV, hepatitis B, and/or hepatitis C.
11. Having active Tuberculosis.
12. Psychiatric condition that precludes compliance with the protocol.
13. Suspected or known current alcohol or drug abuse as per discretion of
the PI.
14. Any other finding that, in the judgment of the Investigator, would
interfere with, or serve as a contraindication to, protocol adherence,
assessment of safety or reactogenicity, or a subject s ability to give
informed consent, or increase the risk of having an adverse outcome
from participating in the study.
15. Any skin disease or history of skin disease that may interfere with the
study evaluation that, in the opinion of the investigator, would interfere
with the study medication application or study assessments.
16. Subject who has a history of serious local infection (e.g., cellulitis,
abscess) or systemic infection, or history of treated infection (e.g.,
pneumonia, septicemia) within 3 months prior to the screening visit.
17. History of allergic disorders including skin allergies and atopic diseases
such as eczema, asthma and rhinoconjunctivitis.
18. Subjects on an antibiotic for a non-serious, acute local infection must
complete the course prior to enrollment into the study.
19. Sexually active man with a partner of child-bearing potential not using
barrier contraception during the trial and for a period of the study.
20. Participation in a clinical trial for an investigational agent within 30 days
or 5 half-lives of the investigational agent (whichever is longer) of
screening.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate safety and tolerability of AB1001 topical gel
when establishing the MTD (Maximum Tolerated Dose) or the MAD
(Maximum Administered Dose) in healthy subjects -Time Frame: 2 weeks as
assessed by:
1. General Examination of the skin for any local inflammatory reaction and local intolerance
Safety concerns as measured by:
a. Clinical Signs and Symptoms as measured by Physical Examination, Vital
signs, and ECG.
b. Clinical Chemistry: CBC, LFT, RFT, Blood Glucose, Thyroid Profile.
1. Day 4, Day 8, and Day 15
a. at the time of screening, Day 1, Day 4, Day 8, Day 13, Day 14 and Day 15
b. at the time of screening and Day 15
Secondary Outcome
Outcome
TimePoints
a. Single dose PK: Quantification of AB1001 concentration available in systemic circulation (blood/plasma) in all enrolled subjects; pre- and post first dosing with AB1001 gel on Day 1.
b. Multi dose PK: Quantification of AB1001 concentration available in systemic circulation (blood/plasma) in all enrolled subjects; pre- and post morning dosing with AB1001 gel on Day 14.
a. Time points for sample collection: 30 minutes pre-morning dose and 1, 3, 6, 9, 12, 24 hours post-morning dose.
b. Time points for sample collection: 30 minutes pre-morning dose and 1, 3, 6, 9, 12, 24 hours postmorning dose.
Target Sample Size
Total Sample Size="30" Sample Size from India="30" 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)
01/02/2022
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="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
NIL
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The overall objective of the study is to assess the safety, tolerability and pharmacokinetics of topical AB1001 gel in healthy volunteers.
Primary Objective: To evaluate safety and tolerability of AB1001 topical gel when establishing the MTD (Maximum Tolerated Dose) or the MAD (Maximum Administered Dose) in healthy subjects [Time Frame: 2 weeks] as assessed by:
1. General Examination of the skin for any local inflammatory reactions and local intolerance
2. Safety concerns as measured by:
3. Clinical Signs and Symptoms by means of Physical Examination, Vital signs, and ECG.
1. Single dose PK: Quantification of AB1001 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- first dosing with AB1001 gel on Day 1. Time points for sample collection: 30 minutes pre-morning dose and 1, 3, 6, 9, 12, 24 hours post-morning dose. Sample will be drawn to calculate Cmax, Tmax, AUC(0-12), AUC(0-24).
2. Multi dose PK: Quantification of AB1001 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- morning dosing with AB1001 gel on Day 14. Time points for sample collection: 30 minutes premorning dose and 1, 3, 6, 9, 12, 24 hours post-morning dose. Sample will be drawn to calculate Cmax, Tmax, AUC(0-12), AUC(0-24).