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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SYHX2008 injection
Octreotide Acetate Microspheres for Injection injection
Sandostatin ® injection
Placebo to SYHX2008 injection
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

22 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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; The subject has participated in other clinical trials within 3 months before administration of investigational product; The subject donated blood or lost blood >400 mL (except female physiological period) within 3 months before screening; 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); 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; 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; According to the investigator's judgment, there are other situations that are not suitable for participating in this clinical trial.

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

5 mg cohort

10 mg cohort

20 mg cohort

30 mg cohort

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

Sandostatin® 0.1mg cohort

Arm 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).

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

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

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

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

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

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events

Secondary Outcome Measures

Area under the plasma concentration-time curve (AUC)
AUC from pre-dose to time 't' (AUC[0-t]) and pre-dose to infinite time (AUC[0-infinity]) of Octreotide
Maximum plasma concentration (Cmax)
Maximum octreotide plasma concentration (Cmax) of Octreotide
Time to maximum plasma concentration (Tmax)
Time to maximum octreotide plasma concentration (Tmax) of Octreotide
Terminal elimination half-life (t1/2)
Plasma decay half-life is the time measured for the octreotide plasma concentration to decrease by one half.
Apparent systemic clearance (CL/F)
CL/F is the volume of plasma cleared of octreotide per unit time.
Apparent volume of distribution (Vz/F)
Vz/F is the apparent volume of distribution of octreotide during the terminal elimination phase .
Insulin-like growth factor-1 (IGF-1) concentrations over time.
IGF-1 levels will be collected over time to compare the suppressive ability of octreotide.

Full Information

First Posted
February 13, 2023
Last Updated
October 7, 2023
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05761431
Brief Title
A Single-dose Study of Octreotide Injection in Healthy Adult Subjects
Official Title
A Single-dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Octreotide Injection in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
June 28, 2023 (Actual)
Study Completion Date
June 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 mg cohort
Arm Type
Experimental
Arm 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).
Arm Title
10 mg cohort
Arm Type
Experimental
Arm 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).
Arm Title
20 mg cohort
Arm Type
Experimental
Arm 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).
Arm Title
30 mg cohort
Arm Type
Experimental
Arm 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).
Arm Title
Octreotide long-acting release ( Sandostatin LAR®) 20 mg cohort
Arm Type
Experimental
Arm Description
Subjects will be treated with single dose of octreotide long-acting release ( Sandostatin LAR®) at dose of 20 mg.
Arm Title
Sandostatin® 0.1mg cohort
Arm Type
Experimental
Arm Description
Subjects will be treated with single dose of Sandostatin® at dose of 0.1mg.
Intervention Type
Drug
Intervention Name(s)
SYHX2008 injection
Intervention Description
Subcutaneous administration on Day 1.
Intervention Type
Drug
Intervention Name(s)
Octreotide Acetate Microspheres for Injection injection
Intervention Description
Intramuscular administration on Day 1.
Intervention Type
Drug
Intervention Name(s)
Sandostatin ® injection
Intervention Description
Subcutaneous administration on Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo to SYHX2008 injection
Intervention Description
Subcutaneous administration on Day 1.
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events
Time Frame
Throughout the study period, with an average of 60 days.
Secondary Outcome Measure Information:
Title
Area under the plasma concentration-time curve (AUC)
Description
AUC from pre-dose to time 't' (AUC[0-t]) and pre-dose to infinite time (AUC[0-infinity]) of Octreotide
Time Frame
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.
Title
Maximum plasma concentration (Cmax)
Description
Maximum octreotide plasma concentration (Cmax) of Octreotide
Time Frame
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.
Title
Time to maximum plasma concentration (Tmax)
Description
Time to maximum octreotide plasma concentration (Tmax) of Octreotide
Time Frame
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.
Title
Terminal elimination half-life (t1/2)
Description
Plasma decay half-life is the time measured for the octreotide plasma concentration to decrease by one half.
Time Frame
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.
Title
Apparent systemic clearance (CL/F)
Description
CL/F is the volume of plasma cleared of octreotide per unit time.
Time Frame
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.
Title
Apparent volume of distribution (Vz/F)
Description
Vz/F is the apparent volume of distribution of octreotide during the terminal elimination phase .
Time Frame
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.
Title
Insulin-like growth factor-1 (IGF-1) concentrations over time.
Description
IGF-1 levels will be collected over time to compare the suppressive ability of octreotide.
Time Frame
Pre-dose, 1 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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; The subject has participated in other clinical trials within 3 months before administration of investigational product; The subject donated blood or lost blood >400 mL (except female physiological period) within 3 months before screening; 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); 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; 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; According to the investigator's judgment, there are other situations that are not suitable for participating in this clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang NA Lin, PhD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shan NA Jing, PhD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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