A Single-dose Study of Octreotide Injection in Healthy Adult Subjects

CSPC Pharmaceutical Group

Status and phase: Completed; Phase 1

Conditions: Acromegaly

Treatments: Drug: Octreotide Acetate Microspheres for Injection injection; Drug: Placebo to SYHX2008 injection; Drug: Sandostatin ® injection; Drug: SYHX2008 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05761431

SYHX2008-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 22 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy, adult, male and female subjects, 22-45 years of age, inclusive, at screening;
2. Body weight≥50 kg in male subjects or≥45 kg in female subjects, with BMI 19.0 - 28.0 kg/m^2 (inclusive);
3. 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;
4. No clinically relevant findings in the physical examination, ECG, abdominal ultrasonography, vital signs, laboratory examination by investigator's assessment;
5. 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;
6. 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

1. 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;
2. The female subject of childbearing potential, is pregnant (as based on test results in the screening period) or is breast feeding;
3. The subject with any one of HBsAg, hepatitis C antibody, anti-HIV antibody and antibody of treponema pallidum positive;
4. 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;
5. The subject has a history of acupuncture syncope or blood phobia, or has difficulty with vein blood collection or venipuncture;
6. The subject has difficulty with subcutaneous administration;
7. The subject has a history of drug abuse or dependence, or has a positive result of drug abuse test in urine;
8. 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;
9. 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;
10. The subject has a history of hospitalization or surgical operation within 3 months before screening;
11. The subject has participated in other clinical trials within 3 months before administration of investigational product;
12. The subject donated blood or lost blood >400 mL (except female physiological period) within 3 months before screening;
13. The subject received prescription or non-prescription drugs within 28 days before administration of investigational product, including the drug effect on growth hormone and insulin-like growth factor (such as epinephrine, cholinergic drugs, etc); or received dietary supplements within 7 days before administration of investigational product (such as vitamin, protein powder, etc);
14. The subject with consumption of food or beverage containing caffeine or xanthine within 72 hours before administration of investigational product (such as coffee, tea, cola, chocolate, etc), or grapefruit fruit, or products containing grapefruit ingredients;
15. The subject has received any products containing alcohol within 48 hours before administration of investigational product or has a positive result of breath alcohol test;
16. According to the investigator's judgment, there are other situations that are not suitable for participating in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 6 patient groups

5 mg cohort

Experimental group

Description:

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).

Treatment:

Drug: Placebo to SYHX2008 injection

Drug: SYHX2008 injection

10 mg cohort

Experimental group

Description:

Subjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 10 mg (8 active : 2 placebo).

Treatment:

Drug: Placebo to SYHX2008 injection

Drug: SYHX2008 injection

20 mg cohort

Experimental group

Description:

Subjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 20 mg (8 active : 2 placebo).

Treatment:

Drug: Placebo to SYHX2008 injection

Drug: SYHX2008 injection

30 mg cohort

Experimental group

Description:

Subjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 30 mg (8 active : 2 placebo).

Treatment:

Drug: SYHX2008 injection

Octreotide long-acting release ( Sandostatin LAR®) 20 mg cohort

Experimental group

Description:

Subjects will be treated with single dose of octreotide long-acting release ( Sandostatin LAR®) at dose of 20 mg.

Treatment:

Drug: Octreotide Acetate Microspheres for Injection injection

Sandostatin® 0.1mg cohort

Experimental group

Description:

Subjects will be treated with single dose of Sandostatin® at dose of 0.1mg.

Treatment:

Drug: Sandostatin ® injection