A Single-dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Octreotide Injection in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- SYHX2008 injection
- Conditions
- Acromegaly
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Incidence and severity of adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a single-centre, single-dose, dose-escalation, placebo and positive drug-controlled Phase I clinical study in healthy Chinese subjects to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of octreotide injection in healthy Chinese subjects.
Detailed Description
This single centre study will be comprised of 6 cohorts. The single ascending dose part is comprises of 4 cohorts（5 mg, 10 mg, 20 mg, 30 mg). The other 2 cohorts are octreotide long-acting release ( Sandostatin LAR® ) 20 mg and Sandostatin® 0.1 mg.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy, adult, male and female subjects, 22-45 years of age, inclusive, at screening;
- •Body weight≥50 kg in male subjects or≥45 kg in female subjects, with BMI 19.0 - 28.0 kg/m\^2 (inclusive);
- •Good health without history of cardiovascular vascular, liver, kidney, respiratory system, digestive, nervous, blood, immune, cancer, endocrine disease or any system diseases that have completely recovery or no clinical significance by investigator's assessment;
- •No clinically relevant findings in the physical examination, ECG, abdominal ultrasonography, vital signs, laboratory examination by investigator's assessment;
- •Informed consent documents signed by subjects prior the study, and subjects could be able to read, comprehend the procedure or the adverse reaction about the trial;
- •Subjects (including female and male subjects) have no pregnancy plan and sperm (egg) donation plan and voluntarily take effective contraceptive methods from signing the informed consent form until 3 months after administration of investigational product.
Exclusion Criteria
- •The subject has a history of sensitivity (such as asthma, urticaria, eczema, etc), or has a known hypersensitivity to any of the test materials or related compounds, or has allergic constitution;
- •The female subject of childbearing potential, is pregnant (as based on test results in the screening period) or is breast feeding;
- •The subject with any one of HBsAg, hepatitis C antibody, anti-HIV antibody and antibody of treponema pallidum positive;
- •The subject with chronic or acute gastrointestinal disease (such as dyspepsia, gastro-oesophageal reflux, gastric bleeding or peptic ulcer, etc), or has a history of gallbladder disease (such as gallstone, cholecystectomy, etc) and other diseases;
- •The subject has a history of acupuncture syncope or blood phobia, or has difficulty with vein blood collection or venipuncture;
- •The subject has difficulty with subcutaneous administration;
- •The subject has a history of drug abuse or dependence, or has a positive result of drug abuse test in urine;
- •The subject intake more than 14 units alcohol within 3 months before administration of investigational product (1 unit=360 mL of beer, or 45 mL spirits, or 150 mL grape wine), or can't control to drink alcohol;
- •The subject smoke more than 5 cigarettes per day within 3 months before administration of investigational product, or smoke within 48h before administration of investigational product, or are unwilling to stop any tobacco products;
- •The subject has a history of hospitalization or surgical operation within 3 months before screening;
Arms & Interventions
5 mg cohort
Subjects will be randomly assigned 4:1 to single dose of either SYHX2008（octreotide long-acting injection) or placebo at dose of 5 mg (8 active : 2 placebo).
Intervention: SYHX2008 injection
5 mg cohort
Subjects will be randomly assigned 4:1 to single dose of either SYHX2008（octreotide long-acting injection) or placebo at dose of 5 mg (8 active : 2 placebo).
Intervention: Placebo to SYHX2008 injection
10 mg cohort
Subjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 10 mg (8 active : 2 placebo).
Intervention: SYHX2008 injection
10 mg cohort
Subjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 10 mg (8 active : 2 placebo).
Intervention: Placebo to SYHX2008 injection
20 mg cohort
Subjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 20 mg (8 active : 2 placebo).
Intervention: SYHX2008 injection
20 mg cohort
Subjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 20 mg (8 active : 2 placebo).
Intervention: Placebo to SYHX2008 injection
30 mg cohort
Subjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 30 mg (8 active : 2 placebo).
Intervention: SYHX2008 injection
Octreotide long-acting release ( Sandostatin LAR®) 20 mg cohort
Subjects will be treated with single dose of octreotide long-acting release ( Sandostatin LAR®) at dose of 20 mg.
Intervention: Octreotide Acetate Microspheres for Injection injection
Sandostatin® 0.1mg cohort
Subjects will be treated with single dose of Sandostatin® at dose of 0.1mg.
Intervention: Sandostatin ® injection
Outcomes
Primary Outcomes
Incidence and severity of adverse events
Time Frame: Throughout the study period, with an average of 60 days.
Secondary Outcomes
- Time to maximum plasma concentration (Tmax)(Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.)
- Apparent systemic clearance (CL/F)(Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.)
- Terminal elimination half-life (t1/2)(Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.)
- Apparent volume of distribution (Vz/F)(Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.)
- Insulin-like growth factor-1 (IGF-1) concentrations over time.(Pre-dose, 1 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.)
- Area under the plasma concentration-time curve (AUC)(Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.)
- Maximum plasma concentration (Cmax)(Pre-dose, 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.)