COVID 19Phase 1NCT04583228
Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 (Recombinant Human Angiotensin-converting Enzyme 2-Fc Fusion Protein for COVID-19) in Healthy Adult Subjects
A Phase 1 study testing HLX71 in people with COVID 19, run by Hengenix Biotech Inc at 1 site in United States.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID 19
- What is being tested?
- HLX71
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2021to 20 Jul 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with voluntary signing of the informed consent form (ICF), and capable of understanding and following the requirements.
- Healthy males or females aged ≥ 18 and < 65 years at the time of signing the ICF.
- Body weight ≥ 50.0 kg and < 100.0 kg, and body mass index (BMI) ≥ 18.5 kg/m2 and < 30.0 kg/m2.
- The subject is in good health as determined by the Investigator according to medical history, physical examination, vital signs, 12-lead ECG, chest X-ray, and laboratory tests (hematology, serum chemistry, C-reactive protein, thyroid function, coagulation, etiology, urinalysis).
- No plan of pregnancy and being willing to use continuous effective contraception for subjects (including partner) from informed consent to 6 months after administration of investigational product, see Appendix 1 for the specific contraceptive measures.
Who cannot join
- Subjects with the lab-confirmed medical history of COVID-19, including SARS-CoV-2 determined by reverse transcription-polymerase chain reaction (RT-PCR) or positive specific antibody IgM or IgG against serum SARS-CoV-2.
- Subjects with the novel onset of pyrexia/cough/shortness of breath/diarrhea or history of contact with confirmed COVID-19 individuals within the 14 days before randomization.
- Pneumonia or active tuberculosis (TB) indicated by chest X-Ray, or abnormal and clinically significant as judged by the Investigator.
- Abnormal blood pressure or pulse rate: systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg, SBP ≤ 90 mmHg or DBP < 60 mmHg, pulse rate < 50 beats /min or > 100 beats/min at screening and clinically significant as judged by the Investigator.
- Clinically significant 12-lead ECG abnormalities, or QTcF interval > 450 msec at screening, or history of clinically significant ECG abnormalities, which may increase the risk to the subject as judged by the Investigator.
- Use of monoclonal antibodies or fusion proteins within 6 months before screening.
Show all 19Show fewer
- Subjects with previous exposure to vaccines in 3 months before screening, or who plans to receive vaccination during the study period or in 3 months after the study.
- History of allergy to any monoclonal antibody, fusion protein, biological product, protein product, or ingredient of the IP.
- Family history of cardiovascular disease, history of atherosclerosis, presence of chronic obstructive pulmonary disease (COPD), cirrhosis, cardiovascular disease, or any condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being.
- History of blood loss or blood donation (including blood component donation) ≥ 400 mL, or reception of blood transfusion within 3 months prior to screening; blood loss or donation (including blood component donation) ≥ 200 mL within 1 month prior to screening.
- Previous surgery within 2 months before screening, or scheduled surgery during the study.
- Previous administration of any investigational drugs/comparators in clinical trials within 3 0 days or remaining in the elimination period of the drug (within 5 half-lives) before screening, or still in the follow-up period of a certain clinical study.
- Use of prescribed drugs, over-the-counter (OTC) drugs, or herbal medicines (excluding vitamins and mineral supplements) within 14 days before screening.
- History of alcohol abuse or intake of excessive alcohol in the past 6 months (15 unit of alcohol per week: 1 unit = 285 mL beer, or 25 mL liquor, or 100 mL wine), or alcohol breath test positive, or unwilling/unable to quit alcohol drinking during the study.
- Subjects who smoke ≥ 5 cigarettes per day or are positive in tobacco screening , or those who are unwilling/unable to quit nicotine intake during the study.
- Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV) antibody, treponema pallidumparticle agglutination test (TPPA) or Tuberculosis (TB) quantiferon at screening.
- Positive β-Human Chorionic Gonadotropin (β-HCG) or breastfeeding female subjects.
- History of narcotics abuse or addiction, or positive drug screening.
- Other conditions unsuitable for participation in the study determined by the Investigator, such as potential compliance issues, inability to complete all tests and evaluations required in the protocol, and uncontrolled psychiatric or mental illnesses.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 in Healthy Adult Subjects
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 in Healthy Adult Subjects
Read the detailed description
A randomized, double-blind, single-dose by intravenous administration, placebo-controlled, dose escalation, first-in-human study is proposed to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and immunogenicity of HLX71 in healthy subjects. Investigators plan to enroll 10 subjects in each of the 4 dose cohorts at 2.5 mg/kg, 5 mg/ kg, 10 mg/kg and 15 mg/kg, of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the investigational product (IP). A total of 40 subjects will be enrolled.
- Conditions
- COVID 19
- Being tested
- HLX71, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX71Drug
Also called Recombinant Human Angiotensin-Converting Enzyme 2-Fc Fusion Protein
Single-dose, intravenous infusion
PlaceboOther
Single-dose, intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Random allocation to HLX71 1 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the HLX71. Receives: Drug: HLX71; Other: Placebo |
| Sequence 2 | Experimental | Random allocation to HLX71 3 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the HLX71. Receives: Drug: HLX71; Other: Placebo |
| Sequence 3 | Experimental | Random allocation to HLX71 10 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the HLX71. Receives: Drug: HLX71; Other: Placebo |
| Sequence 4 | Experimental | Random allocation to HLX71 15 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the HLX71. Receives: Drug: HLX71; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0
Measured: up to 28 days
The proportion of subjects undergoing DLT events in each dose cohorts during the DLT observation period
Measured: Days 1 to 7
Secondary outcomes (14)
PK parameters-Peak concentration
Measured: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Time to peak
Measured: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Areas under the concentration-time curves
Measured: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Terminal elimination rate constant
Measured: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Elimination half-life
Measured: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Clearance (CL)
Measured: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Volume of distribution
Measured: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
The concentration-time curves of plasma Ang1-10
Measured: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-9
Measured: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-8
Measured: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-7
Measured: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma aldosterone
Measured: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
ADA positive rate
Measured: Day 15 and 29
NAb positive rate
Measured: Day 15 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start8 Apr 2021
- Primary completion15 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The investigators plan to enroll 8 subjects in each sequence, of which 2 receive intravenous injection of placebo and 6 receive intravenous injection of IP. Subjects are allocated in two groups randomly.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hengenix Biotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Lee, MD, Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583228
- Sponsor's protocol ID
- HLX71-001US-253460
- Status last verified
- Mar 2022
- First submitted
- 25 Sep 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04583228
- Acronym / sponsor ID
- HLX71-001US-253460
- Conditions
- COVID 19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hengenix Biotech IncIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 12 Oct 2020 (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 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of HLX71 in Healthy Adult Subjects
Detailed description
A randomized, double-blind, single-dose by intravenous administration, placebo-controlled, dose escalation, first-in-human study is proposed to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and immunogenicity of HLX71 in healthy subjects. Investigators plan to enroll 10 subjects in each of the 4 dose cohorts at 2.5 mg/kg, 5 mg/ kg, 10 mg/kg and 15 mg/kg, of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the investigational product (IP). A total of 40 subjects will be enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The investigators plan to enroll 8 subjects in each sequence, of which 2 receive intravenous injection of placebo and 6 receive intravenous injection of IP. Subjects are allocated in two groups randomly.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HLX71, Other: PlaceboRandom allocation to HLX71 1 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the HLX71. |
| Sequence 2 | Experimental | Drug: HLX71, Other: PlaceboRandom allocation to HLX71 3 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the HLX71. |
| Sequence 3 | Experimental | Drug: HLX71, Other: PlaceboRandom allocation to HLX71 10 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the HLX71. |
| Sequence 4 | Experimental | Drug: HLX71, Other: PlaceboRandom allocation to HLX71 15 mg/kg (IV, single dose), or placebo (IV, single dose) of which 2 receive intravenous injections of placebo and 8 receive intravenous injections of the HLX71. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with voluntary signing of the informed consent form (ICF), and capable of understanding and following the requirements.
- Healthy males or females aged ≥ 18 and < 65 years at the time of signing the ICF.
- Body weight ≥ 50.0 kg and < 100.0 kg, and body mass index (BMI) ≥ 18.5 kg/m2 and < 30.0 kg/m2.
- The subject is in good health as determined by the Investigator according to medical history, physical examination, vital signs, 12-lead ECG, chest X-ray, and laboratory tests (hematology, serum chemistry, C-reactive protein, thyroid function, coagulation, etiology, urinalysis).
- No plan of pregnancy and being willing to use continuous effective contraception for subjects (including partner) from informed consent to 6 months after administration of investigational product, see Appendix 1 for the specific contraceptive measures.
Key exclusion criteria (19 listed)
- Subjects with the lab-confirmed medical history of COVID-19, including SARS-CoV-2 determined by reverse transcription-polymerase chain reaction (RT-PCR) or positive specific antibody IgM or IgG against serum SARS-CoV-2.
- Subjects with the novel onset of pyrexia/cough/shortness of breath/diarrhea or history of contact with confirmed COVID-19 individuals within the 14 days before randomization.
- Pneumonia or active tuberculosis (TB) indicated by chest X-Ray, or abnormal and clinically significant as judged by the Investigator.
- Abnormal blood pressure or pulse rate: systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg, SBP ≤ 90 mmHg or DBP < 60 mmHg, pulse rate < 50 beats /min or > 100 beats/min at screening and clinically significant as judged by the Investigator.
- Clinically significant 12-lead ECG abnormalities, or QTcF interval > 450 msec at screening, or history of clinically significant ECG abnormalities, which may increase the risk to the subject as judged by the Investigator.
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 |
|---|---|---|
| HLX71Also: Recombinant Human Angiotensin-Converting Enzyme 2-Fc Fusion ProteinSingle-dose, intravenous infusion | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| PlaceboSingle-dose, intravenous infusion | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0
Time frame: up to 28 days
The proportion of subjects undergoing DLT events in each dose cohorts during the DLT observation period
Time frame: Days 1 to 7
14 secondary outcomes
PK parameters-Peak concentration
Time frame: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Time to peak
Time frame: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Areas under the concentration-time curves
Time frame: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Terminal elimination rate constant
Time frame: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Elimination half-life
Time frame: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Clearance (CL)
Time frame: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
PK parameters-Volume of distribution
Time frame: Pre-infusion, immediately post-infusion(0 hours), 1, 2.5, 4, 10, 24 hours after end of infusion and on days 3, 4, 6, 8, 10, 12, 15, 18, 22 and 29
The concentration-time curves of plasma Ang1-10
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-9
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-8
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma Ang1-7
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
The concentration-time curves of plasma aldosterone
Time frame: Pre infusion, immediately post-infusion(0 hours), 1, 4, 10, 24 hours after end of infusion and on days 3, 8, 15 and 29
ADA positive rate
Time frame: Day 15 and 29
NAb positive rate
Time frame: Day 15 and 29
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 1 Apr 2022.
- 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.
Frank Lee, MD principal investigator
Frontage Clinical Services, Inc.
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 HLX71 in people with COVID 19, run by Hengenix Biotech Inc at 1 site in United States.
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 5 inclusion and 19 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 1 Apr 2022. 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 United States. 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?
Number of participants with adverse events, serious adverse event and infusion-related reactions as assessed by CTCAE v5.0 (time frame: up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2022.