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CTRI Number  CTRI/2023/10/059183 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study of a medicine named SCD-153, applied on the skin of Healthy Volunteers 
Scientific Title of Study   A Randomized, Double-Blind, Vehicle-Controlled, Study to Evaluate the Safety, Tolerability, & Pharmacokinetics of topically applied SCD-153 in Healthy Volunteers 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
SCD-153-22-01, Initial protocol (A0)-08-Jun-2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mudgal Kothekar 
Designation  Vice President, Clinical Development 
Affiliation  Sun Pharma Advanced Research Limited 
Address  17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)

Mumbai
MAHARASHTRA
400093
India 
Phone  91-22-66455645  
Fax    
Email  clinical.trials@sparcmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mudgal Kothekar 
Designation  Vice President, Clinical Development 
Affiliation  Sun Pharma Advanced Research Limited 
Address  17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)

Mumbai
MAHARASHTRA
400093
India 
Phone  91-22-66455645  
Fax    
Email  clinical.trials@sparcmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mudgal Kothekar 
Designation  Vice President, Clinical Development 
Affiliation  Sun Pharma Advanced Research Limited 
Address  17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E)

Mumbai
MAHARASHTRA
400093
India 
Phone  91-22-66455645  
Fax    
Email  clinical.trials@sparcmail.com  
 
Source of Monetary or Material Support  
Sun Pharma Advanced Research Company Limited 17B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E) Mumbai MAHARASHTRA 400093 India 
 
Primary Sponsor  
Name  Sun Pharma Advanced Research Company Limited 
Address  17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (E), Mumbai 400093, India. 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Raviraj Jagdhani  Raptim Research Pvt. Ltd.  T.T.C. Industrial Area, Mahape M.I.D.C., Navi Mumbai – 400710, India.
Mumbai
MAHARASHTRA 		 912227781889

raviraj.jagdhani@raptimresearch.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sai Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  not applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active-SCD-153  frequency: Single topical application route of administration: topical duration of study: approximately 14 days 
Comparator Agent  Vehicle  frequency: Single topical application route of administration: topical duration of study: approximately 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Healthy male and non-pregnant, non-lactating female volunteers between 18-65 years (both inclusive) of age.
2. Voluntarily given informed consent to participate in this study.
3. Volunteers must have a 12-lead electrocardiogram (ECG), with no abnormalities considered to be clinically significant, as assessed by the Investigator/Sub-Investigator.
4. Clinical laboratory tests are within the normal laboratory reference ranges, or the abnormal values are assessed by the Investigator as clinically not significant.
5. The volunteer must be willing and able to comply with study-related instructions and restrictions and willing to remain confined at the clinic for the required duration during the study and to return to the clinic for the follow-up evaluation as specified in this protocol.  
 
ExclusionCriteria 
Details  1. Participation in an investigational drug study within 90 days prior to screening.
2. Donated blood within 3 months prior to Screening.
3. Clinically significant abnormal physical examination findings.
4. History of drug and/ or alcohol abuse.
5. Has a history of, or any current systemic or dermatologic condition
6. The investigator determines volunteers to have any medical condition that could jeopardize their health or bias the results.
7. Volunteers who refuse to refrain from strenuous physical work or exercise from Screening until the end of the study visit.
8. Volunteers who are related to or dependent on the Investigator, Sponsor, or study site such that a conflict of interest could arise

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety by assessing the incidence & severity of AEs, vital signs, clinical laboratory assessments, physical examination & local tolerability assessments   upto Day 10 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the plasma pharmacokinetic parameters - Cmax, Tmax, AUC0-24, AUC0-t, AUC0-inf, t1/2
2. To assess the urinary pharmacokinetic parameters - cumulative amount eliminated in the urine (Ae), a fraction of the dose eliminated in the urine (Fe), & Renal clearance (CLr)

 		 upto Day 4 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)
Modification(s)  		 28/11/2023 
Date of Study Completion (India) 07/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a first-in-human (FIH), randomized, double-blind, vehicle-controlled, sequential cohorts, single ascending dose evaluation of the non-occluded, topical application of SCD-153.

 
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