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AcromegalyPhase 1NCT05761431

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

A Phase 1 study testing SYHX2008 injection, Octreotide Acetate Microspheres for Injection injection and Sandostatin ® injection in people with Acromegaly, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 22 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Acromegaly
What is being tested?
SYHX2008 injection, Octreotide Acetate Microspheres for Injection injection and Sandostatin ® injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteChina
Study dates
2 Mar 2023to 28 Jun 2023
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: A Single-dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Octreotide Injection in Healthy Adult Subjects

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.

Read the 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.

Conditions
Acromegaly
Being tested
SYHX2008 injection, Octreotide Acetate Microspheres for Injection injection, Sandostatin ® injection, Placebo to SYHX2008 injection
Medical subject headings
Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYHX2008 injectionDrug

    Subcutaneous administration on Day 1.

  • Octreotide Acetate Microspheres for Injection injectionDrug

    Intramuscular administration on Day 1.

  • Sandostatin ® injectionDrug

    Subcutaneous administration on Day 1.

  • Placebo to SYHX2008 injectionDrug

    Subcutaneous administration on Day 1.

Study groups in NCT05761431
Study groupRoleWhat they receive
5 mg cohortExperimentalSubjects 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).
Receives: Drug: SYHX2008 injection; Drug: Placebo to SYHX2008 injection
10 mg cohortExperimentalSubjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 10 mg (8 active : 2 placebo).
Receives: Drug: SYHX2008 injection; Drug: Placebo to SYHX2008 injection
20 mg cohortExperimentalSubjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 20 mg (8 active : 2 placebo).
Receives: Drug: SYHX2008 injection; Drug: Placebo to SYHX2008 injection
30 mg cohortExperimentalSubjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 30 mg (8 active : 2 placebo).
Receives: Drug: SYHX2008 injection
Octreotide long-acting release ( Sandostatin LAR®) 20 mg cohortExperimentalSubjects will be treated with single dose of octreotide long-acting release ( Sandostatin LAR®) at dose of 20 mg.
Receives: Drug: Octreotide Acetate Microspheres for Injection injection
Sandostatin® 0.1mg cohortExperimentalSubjects will be treated with single dose of Sandostatin® at dose of 0.1mg.
Receives: Drug: Sandostatin ® injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events

    Measured: Throughout the study period, with an average of 60 days.

Secondary outcomes (7)

  1. 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

    Measured: 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.

  2. Maximum plasma concentration (Cmax)

    Maximum octreotide plasma concentration (Cmax) of Octreotide

    Measured: 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.

  3. Time to maximum plasma concentration (Tmax)

    Time to maximum octreotide plasma concentration (Tmax) of Octreotide

    Measured: 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.

  4. Terminal elimination half-life (t1/2)

    Plasma decay half-life is the time measured for the octreotide plasma concentration to decrease by one half.

    Measured: 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.

  5. Apparent systemic clearance (CL/F)

    CL/F is the volume of plasma cleared of octreotide per unit time.

    Measured: 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.

  6. Apparent volume of distribution (Vz/F)

    Vz/F is the apparent volume of distribution of octreotide during the terminal elimination phase .

    Measured: 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.

  7. 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.

    Measured: Pre-dose, 1 hour, 4 hour, 12 hour, 24 hour, 48 hour, 96 hour, 168 hour, 336 hour, 576 hour, 1008 hour, 1416 hour.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2023
  2. Study start2 Mar 2023
  3. Primary completion28 Jun 2023
  4. Study completion28 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05761431
Sponsor's protocol ID
SYHX2008-001
Status last verified
Oct 2023
First submitted
13 Feb 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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