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
Are there results?: None posted in the registry

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

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 group	Role	What they receive
5 mg cohort	Experimental	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). Receives: Drug: SYHX2008 injection; Drug: Placebo to SYHX2008 injection
10 mg cohort	Experimental	Subjects 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 cohort	Experimental	Subjects 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 cohort	Experimental	Subjects 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 cohort	Experimental	Subjects 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 cohort	Experimental	Subjects 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.

Incidence and severity of adverse events
Measured: Throughout the study period, with an average of 60 days.

Secondary outcomes (7)

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.
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.
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.
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.
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.
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.
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.

2 Mar 202328 Jun 2023

First posted9 Mar 2023
Study start2 Mar 2023
Primary completion28 Jun 2023
Study completion28 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AcromegalyStudies of the same condition, open and under way.
More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

All Acromegaly trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Octreotide Injection in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT05761431
Acronym / sponsor ID: SYHX2008-001
Conditions: Acromegaly
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 2 Mar 2023 (actual)
Primary completion: 28 Jun 2023 (actual)
Study completion: 28 Jun 2023 (actual)
First posted: 9 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
5 mg cohort	Experimental	Drug: SYHX2008 injection, Drug: Placebo to SYHX2008 injectionSubjects 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).
10 mg cohort	Experimental	Drug: SYHX2008 injection, Drug: Placebo to SYHX2008 injectionSubjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 10 mg (8 active : 2 placebo).
20 mg cohort	Experimental	Drug: SYHX2008 injection, Drug: Placebo to SYHX2008 injectionSubjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 20 mg (8 active : 2 placebo).
30 mg cohort	Experimental	Drug: SYHX2008 injectionSubjects will be randomly assigned 4:1 to single dose of either SYHX2008 or placebo at dose of 30 mg (8 active : 2 placebo).
Octreotide long-acting release ( Sandostatin LAR®) 20 mg cohort	Experimental	Drug: Octreotide Acetate Microspheres for Injection injectionSubjects will be treated with single dose of octreotide long-acting release ( Sandostatin LAR®) at dose of 20 mg.
Sandostatin® 0.1mg cohort	Experimental	Drug: Sandostatin ® injectionSubjects will be treated with single dose of Sandostatin® at dose of 0.1mg.

Who may qualify

Ages: 22 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SYHX2008 injectionSubcutaneous administration on Day 1.	Drug	10 mg cohort, 20 mg cohort, 30 mg cohort, 5 mg cohort
Octreotide Acetate Microspheres for Injection injectionIntramuscular administration on Day 1.	Drug	Octreotide long-acting release ( Sandostatin LAR®) 20 mg cohort
Sandostatin ® injectionSubcutaneous administration on Day 1.	Drug	Sandostatin® 0.1mg cohort
Placebo to SYHX2008 injectionSubcutaneous administration on Day 1.	Drug	10 mg cohort, 20 mg cohort, 5 mg cohort

Primary outcome

Incidence and severity of adverse events
Time frame: Throughout the study period, with an average of 60 days.

7 secondary outcomes

Area under the plasma concentration-time curve (AUC)
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.
Maximum plasma concentration (Cmax)
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.
Time to maximum plasma concentration (Tmax)
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.
Terminal elimination half-life (t1/2)
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.
Apparent systemic clearance (CL/F)
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.
Apparent volume of distribution (Vz/F)
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.
Insulin-like growth factor-1 (IGF-1) concentrations over time.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Individual participant dataSharing planned: No

Related trials for Acromegaly

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yang NA Lin, PhD principal investigator

Beijing Anzhen Hospital

Shan NA Jing, PhD principal investigator

Beijing Anzhen Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (time frame: Throughout the study period, with an average of 60 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05761431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.