Non-alcoholic SteatohepatitisPhase 1NCT04829123

The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects

A Phase 1 study testing HEC88473 injection in people with Non-alcoholic Steatohepatitis, run by Dongguan HEC Biopharmaceutical R&D Co., Ltd. at 1 site in Australia.

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

A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Non-alcoholic Steatohepatitis
What is being tested?: HEC88473 injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteAustralia
Study dates: 14 May 2021to 2 Mar 2022
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
Body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening as assessed by the investigator (or designee).
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Who cannot join

Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing.
Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in.
Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to the first dosing or planned vaccination during the course of the study.
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to the first dosing.
Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dosing, unless deemed acceptable by the investigator (or designee).

Trial locations and contacts

1 site in 1 country.

Australia1 site

Scientia Clinical Research
Sydney

Other trials in Australia

About this study

Official title: A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects

A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects

Read the detailed description

This is the first time HEC88473 will be administered to humans. The aim of this study is to obtain safety, tolerability, PK, PD, and immunogenicity data of HEC88473 SC administration as single and multiple ascending doses in healthy subjects.

Conditions: Non-alcoholic Steatohepatitis
Being tested: HEC88473 injection, Placebo
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

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

HEC88473 injectionDrug
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen
PlaceboDrug
Placebo will be administered by subcutaneous injection in the abdomen

Study groups in NCT04829123
Study group	Role	What they receive
Single dose of 0.5 mg HEC88473	Experimental	Healthy subjects, receiving a single dose of 0.5 mg HEC88473 (N=6) or placebo(N=2) after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 1.7 mg HEC88473	Experimental	Healthy subjects, receiving a single dose of 1.7 mg HEC88473 (N=6) or placebo(N=2) after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 5.1 mg HEC88473	Experimental	Healthy subjects, receiving a single dose of 5.1 mg HEC88473 (N=6) or placebo(N=2) after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 10.2 mg HEC88473	Experimental	Healthy subjects, receiving a single dose of 10.2 mg HEC88473 (N=6) or placebo(N=2) after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 17.0 mg HEC88473	Experimental	Healthy subjects, receiving a single dose of 17.0 mg HEC88473 (N=6) or placebo(N=2) after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 25.5 mg HEC88473	Experimental	Healthy subjects, receiving a single dose of 25.5 mg HEC88473 (N=6) or placebo(N=2) after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 34.0 mg HEC88473	Experimental	Healthy subjects, receiving a single dose of 34.0 mg HEC88473 (N=6) or placebo(N=2) after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Single dose of 44.2 mg HEC88473	Experimental	Healthy subjects, receiving a single dose of 44.2 mg HEC88473 (N=6) or placebo(N=2) after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Multiple doses of 1.7 mg HEC88473	Experimental	Healthy subjects, receiving a weekly dose of 1.7 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Multiple doses of 5.1 mg HEC88473	Experimental	Healthy subjects, receiving a weekly dose of 5.1 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal. Receives: Drug: HEC88473 injection; Drug: Placebo
Multiple doses of 10.2 mg HEC88473	Experimental	Healthy subjects, receiving a weekly dose of 10.2 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal. Receives: Drug: HEC88473 injection; Drug: Placebo

What is being measured

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

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
Measured: Baseline to day 15
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
Measured: Baseline to day 43
Cmax
Maximum observed plasma concentration of HEC88473
Measured: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
AUC
Area under the plasma concentration-time curve (AUC)
Measured: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours

Secondary outcomes (2)

OGTT
Oral glucose tolerance test
Measured: Predose and postdose 2, 4 hours
Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
Measured: Baseline to day 43

Timeline

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

14 May 20212 Mar 2022

First posted2 Apr 2021
Study start14 May 2021
Primary completion2 Mar 2022
Study completion2 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
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: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04829123
Sponsor's protocol ID: HEC88473-DM-102
Status last verified: Feb 2023
First submitted: 25 Mar 2021
Last updated: 15 Feb 2023
Results posted: 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?

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All Non-alcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
ClinicalTrials.gov ID: NCT04829123
Acronym / sponsor ID: HEC88473-DM-102
Conditions: Non-alcoholic Steatohepatitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
Study start: 14 May 2021 (actual)
Primary completion: 2 Mar 2022 (actual)
Study completion: 2 Mar 2022 (actual)
First posted: 2 Apr 2021 (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.

A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 11

Arm	Type	Receives
Single dose of 0.5 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a single dose of 0.5 mg HEC88473 (N=6) or placebo(N=2) after meal.
Single dose of 1.7 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a single dose of 1.7 mg HEC88473 (N=6) or placebo(N=2) after meal.
Single dose of 5.1 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a single dose of 5.1 mg HEC88473 (N=6) or placebo(N=2) after meal.
Single dose of 10.2 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a single dose of 10.2 mg HEC88473 (N=6) or placebo(N=2) after meal.
Single dose of 17.0 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a single dose of 17.0 mg HEC88473 (N=6) or placebo(N=2) after meal.
Single dose of 25.5 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a single dose of 25.5 mg HEC88473 (N=6) or placebo(N=2) after meal.
Single dose of 34.0 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a single dose of 34.0 mg HEC88473 (N=6) or placebo(N=2) after meal.
Single dose of 44.2 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a single dose of 44.2 mg HEC88473 (N=6) or placebo(N=2) after meal.
Multiple doses of 1.7 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a weekly dose of 1.7 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
Multiple doses of 5.1 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a weekly dose of 5.1 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.
Multiple doses of 10.2 mg HEC88473	Experimental	Drug: HEC88473 injection, Drug: PlaceboHealthy subjects, receiving a weekly dose of 10.2 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
Body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening as assessed by the investigator (or designee).
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Key exclusion criteria (8 listed)

Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing.
Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in.

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
HEC88473 injectionHEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen	Drug	Multiple doses of 1.7 mg HEC88473, Multiple doses of 10.2 mg HEC88473, Multiple doses of 5.1 mg HEC88473, Single dose of 0.5 mg HEC88473, Single dose of 1.7 mg HEC88473, Single dose of 10.2 mg HEC88473, Single dose of 17.0 mg HEC88473, Single dose of 25.5 mg HEC88473, Single dose of 34.0 mg HEC88473, Single dose of 44.2 mg HEC88473, Single dose of 5.1 mg HEC88473
PlaceboPlacebo will be administered by subcutaneous injection in the abdomen	Drug	Multiple doses of 1.7 mg HEC88473, Multiple doses of 10.2 mg HEC88473, Multiple doses of 5.1 mg HEC88473, Single dose of 0.5 mg HEC88473, Single dose of 1.7 mg HEC88473, Single dose of 10.2 mg HEC88473, Single dose of 17.0 mg HEC88473, Single dose of 25.5 mg HEC88473, Single dose of 34.0 mg HEC88473, Single dose of 44.2 mg HEC88473, Single dose of 5.1 mg HEC88473

Primary outcome

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
Time frame: Baseline to day 15
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
Time frame: Baseline to day 43
Cmax
Time frame: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Maximum observed plasma concentration of HEC88473
AUC
Time frame: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Area under the plasma concentration-time curve (AUC)

2 secondary outcomes

OGTT
Time frame: Predose and postdose 2, 4 hours
Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
Time frame: Baseline to day 43

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 15 Feb 2023.
Individual participant dataSharing planned: No

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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.

Charlotte Lemech, Doctor principal investigator

Scientia Clinical Research

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HEC88473 injection in people with Non-alcoholic Steatohepatitis, run by Dongguan HEC Biopharmaceutical R&D Co., Ltd. at 1 site in Australia.

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 4 inclusion and 8 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 15 Feb 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 Australia. 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?

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473 (time frame: Baseline to day 15). The study lists 4 primary outcomes in all. 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 NCT04829123.

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 15 Feb 2023.