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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- For single dose study: Cmax, AUC0-t, AUC 0-infinity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal healthy volunteers of either sex Age
- •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).
排除标准
- •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.
结局指标
主要结局
For single dose study: Cmax, AUC0-t, AUC 0-infinity
时间窗: 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
For multiple dose study: AUC(0-tau), Cmax,ss
时间窗: 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
次要结局
- Single dose : Tmax, Thalf, AUC0-t//AUC0-infinity, Kel(Multiple dose: Cmin,ss, Tmax,ss,)
研究者
Dr Hiren Prajapati
Veeda Clinical Research Ltd.