A Phase 1 clinical trial of Bone fracture healing compound S007-1500 in healthy Volunteers
Scientific Title of Study
A Phase 1, Randomized, double-blind, Placebo-Controlled, Single dose &
Multiple Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of Bone Fracture Healing Compound S007-1500 in Healthy Volunteers.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CDRI-CLINICAL4/2020 version no 2 dated 22.07.2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Hiren Prajapati
Designation
Principal Investigator
Affiliation
Veeda Clinical Research Ltd.
Address
Veeda Clinical Research Ltd 2nd 3rd & 4th Floor Shivalik Plaza-A Near IIM Ambawadi Ahmedabad
Ahmadabad GUJARAT 380015 India
Phone
07967773000
Fax
Email
Hiren.P1891@veedacr.com
Details of Contact Person Scientific Query
Name
Mr Vivek Kumar Agarwal
Designation
Assistant Vice president
Affiliation
Troikaa Pharmaceuticals Ltd.
Address
Troikaa House-I Satya Marg Bodakdev Ahmadabad GUJARAT India
Ahmadabad GUJARAT 380054 India
Phone
7926856242
Fax
Email
vivekagarwal@troikaapharma.com
Details of Contact Person Public Query
Name
Mr Vivek Kumar Agarwal
Designation
Assistant Vice president
Affiliation
Troikaa Pharmaceuticals Ltd.
Address
Troikaa House-I Satya Marg Bodakdev Ahmadabad GUJARAT India
Troikaa House-I Satya Marg Bodakdev Ahmedabad-380054 Gujarat India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
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 Hiren Prajapati
Veeda Clinical Research Ltd
Veeda Clinical Research Ltd 2nd 3rd & 4th Floor Shivalik Plaza-A Near IIM Ambawadi Ahmedabad Ahmadabad GUJARAT
07967773000
Hiren.P1891@veedacr.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
NA
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Identical placebo of S007-1500 tablets
This is a phase I study for S007-1500 compound. S007-1500 is a bone fracture healing agent. The single dose Phase I study will be carried out and then subsequently multiple dose Phase I study will be carried out. For single dose phase I study, 25 healthy volunteers will be recruited & for multiple dose study, 24 Normal healthy subjects will be recruited.
For single dose study, 25 patients will be divided in to 5 groups. Each group will have 5 subjects.
Group 1: 5 subjects for 10 mg dose or identical placebo
Group 2: 5 subjects for 20 mg dose or identical placebo
Group 3: 5 subjects for 50 mg dose or identical placebo
Group 4: 5 subjects for 100 mg dose or identical placebo
Group 5: 5 subjects for 150 mg dose or identical placebo
In each group 3 subjects will receive single dose of S007-1500 tablet and 2 subjects will receive placebo
For multiple dose: 24 Subjects will be divided in to 2 groups
Group 1: 12 subjects-Nine participants in each group will receive experimental drug at doses of S007-1500 tablet -10mg. Each of these groups will also have 3 other participants who would receive an identical placebo.
Group 2: 12 subjects-Nine participants in each group will receive experimental drug at doses of S007-1500 tablet -50mg for 28 days.
Each of these groups will also have 3 other participants who would receive an identical placebo for 28 days.
This is a phase I study for S007-1500 compound. S007-1500 is a bone fracture healing agent. The single dose Phase I study will be carried out and then subsequently multiple dose Phase I study will be carried out. For single dose phase I study, 25 healthy volunteers will be recruited & for multiple dose study, 24 Normal healthy subjects will be recruited. For single dose study, 25 patients will be divided in to 5 groups. Each group will have 5 subjects. Group 1: 5 subjects for 10 mg dose or identical placebo Group 2: 5 subjects for 20 mg dose or identical placebo Group 3: 5 subjects for 50 mg dose or identical placebo Group 4: 5 subjects for 100 mg dose or identical placebo Group 5: 5 subjects for 150 mg dose or identical placebo In each group 3 subjects will receive single dose of S007-1500 tablet and 2 subjects will receive placebo For multiple dose: 24 Subjects will be divided in to 2 groups Group 1: 12 subjects-Nine participants in each group will receive experimental drug at doses of S007-1500 tablet -10mg. Each of these groups will also have 3 other participants who would receive an identical placebo. Group 2: 12 subjects-Nine participants in each group will receive experimental drug at doses of S007-1500 tablet -50mg for 28 days. Each of these groups will also have 3 other participants who would receive an identical placebo for 28 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
Normal healthy volunteers of either sex
Age 18 - 45 yrs (both inclusive)
Subjects weight within normal range according to normal values for Body Mass Index (between 18.5 and 30.0 kg/m2) (both inclusive) with minimum of 50 kg weight.
Subjects with normal health as determined by personal medical history and clinical examination
Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
Subjects having negative urine alcohol test / breath alcohol test.
Willing to give written informed consent
Willing to comply with protocol requirements
Normal physical & systemic examination
Laboratory examination (including Biochemistry & hematology) within normal limits or at the discretion of the physician
No abnormality detected on X-ray chest & ECG
Subject having clinical acceptable Ultrasound Whole Abdomen and Bone Mineral Density [BMD] within normal range.
No laboratory evidence of hepatic, renal or cardiac dysfunction.
For male Subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects willing to
refrain from donating sperm during the study period and till 3 months after interventional drug intake.
For Female Subjects:
Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as non hormonal intrauterine device
(IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal foam or
Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above or
Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
ExclusionCriteria
Details
Women of child-bearing age group who are either pregnant, lactating or not willing to take adequate contraception measures till 3 months after interventional drug intake
History of having donated blood in the past 3 months.
Medical history of gastric ulcer, duodenal ulcer or esophageal ulcer within 90 days from the time of visit for screening.
A person with the history and/or presence of drug abuse, alcohol abuse (as per the international guidelines of Centre for Disease Control and Prevention) in last six months, HIV, HCV or HBsAg positivity
History of any drug intake (Prescribed medication or OTC medication including vaccines, vitamins and herbal remedies) in the past 30 days (especially any enzyme-inducing agents)
History of participating in any interventional study in the past 3 months
History of allergy or hypersensitivity to any medication
Tobacco user in any form (smoking, chewing tobacco, pan or pan masala, gutkha, masala (containing betel nut and tobacco)).
History of any chronic disease and taking medication, which may interfere with results of study as decided by physician.
History of taking non-allopathic drug in the past 3 months for any illness
History of any major illness in past 1 year which may affect study as decided by physician (viz. meningitis, hepatitis, tuberculosis, having received treatment)
History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
Consumption of xanthine-containing products, and alcohol or any alcohol containing products within 48.00 hours prior to admission. Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
For single dose study: Cmax, AUC0-t, AUC 0-infinity
For multiple dose study: AUC(0-tau), Cmax,ss
Single dose study timepoints (0 h) and 0.25, 0.5, 1, 2, 3, 4, 6, 8,12, 24 and 48 hours post dose.
Multiple dose study timepoints (0 h) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hrs.
On day 7, blood sample will be collected at tmax (as obtained from single dose study).
On 14th day, samples will be collected at pre dose (0 h) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs of study
Secondary Outcome
Outcome
TimePoints
Single dose : Tmax, Thalf, AUC0-t//AUC0-infinity, Kel
Multiple dose: Cmin,ss, Tmax,ss,
Cavg,ss, Degree of Fluctuation, Swing and accumulation ratios
of S007-1500
Single dose study timepoints (0 h) and 0.25, 0.5, 1, 2, 3, 4, 6, 8,12, 24 and 48 hours post dose.
Multiple dose study timepoints (0 h) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hrs.
On day 7, blood sample will be collected at tmax (as obtained from single dose study).
On 14th day, samples will be collected at pre dose (0 h) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs of study
Target Sample Size
Total Sample Size="49" Sample Size from India="49" 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
N/A
Date of First Enrollment (India)
15/09/2026
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="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
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
S007-1500 is a bone fracture healing agent. It is a synthetic pterocarpan. It has potential osteogenic property and shows accelerated fracture repairing. Phase I clinical trial with S007-1500, a novel Fracture Healing agent would be undertaken at Veeda Clinical Research Ltd. with the objective of evaluating its safety and tolerability in normal, healthy, human participants after single and multiple dose administration. Additionally, pharmacokinetics (PK) and pharmacodynamics (PD) of Compound S007-1500 will be characterized in healthy human participants. The single dose Phase I study will be carried out and then subsequently multiple dose Phase I study will be carried out.