add-on Maintenance Treatment of Patients With Severe Eosinophilic AsthmaPhase 1NCT04445038
Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Injection
A Phase 1 study testing 610 in people with add-on Maintenance Treatment of Patients With Severe Eosinophilic Asthma, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects. There are 6 Groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- add-on Maintenance Treatment of Patients With Severe Eosinophilic Asthma
- What is being tested?
- 610
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2020to 1 Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy participants, male or female, aged 18 to 55 (including both ends)
- The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
- Male participants and their partners or female participants must agree to take one or more non-drug contraceptives (such as complete abstinence, contraceptive rings, partner ligation, etc.) , and there is no sperm donation or egg donation plan
- Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
- Participants could communicate well with the researchers and compliance with the trial
Who cannot join
- Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies, and with allergies (multiple drugs and food allergies)
- Subjects who have or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other that can interfere with the study results
- Those who have undergone surgery within the 3 months prior to the trial that will affect the absorption, distribution, metabolism, and excretion of the drug; or those who have undergone surgery within 4 weeks prior to the trial, or plan to undergo surgery during the study
- Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
- Alcoholics or frequent drinkers within 6 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine), or couldn't prohibit alcohol during the trial or alcohol breath test results greater than 0.0 mg / 100 mL
- Those who smoked more than 5 cigarettes per day during the 3 months before screening, or who cannot stop using any tobacco products during the trial
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- Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening (morphine, methamphetamine , Ketamine, ecstasy, marijuana)
- Has taken any prescription medicine, non-prescription medicine, Chinese herbal medicine or health products (vitamins, cod liver oil, etc.) within 14 days before administration
- Has received any monoclonal antibody drugs within 5 half-lives before administration
- Has a history of vaccination within 4 weeks before dosing, or intend to receive vaccines during the study
- Has parasitic infection at present and within 3 months before dosing
- Was previously enrolled in other clinical trials within 3 months
- Blood donors or subjects who lost a lot of blood (> 400 mL, except for women's physiological period) or those who received blood transfusion or used blood products within 3 months
- Can't tolerate venipuncture or has a history of halo needles and halo blood
- Has known or suspected pregnancy or lactation
- Abnormal vital signs (SBP <90 mmHg or ≥140 mmHg, DBP <55 mmHg or ≥90 mmHg; heart rate <50 bpm or> 100 bpm; body temperature (ear temperature) <35.4℃ or > 37.7℃) or abnormal ECG (QTcB male ≥450 ms, female ≥460 ms) or physical examination, laboratory examination, and abdominal ultrasound examination are clinically significant (according to the judgment of clinical research doctors)
- Subjects who are unsuited to the study for any reason, judged by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Xueying Ding, D.M.
Jigang Zhang, 18621155781, grissomzhang@hotmail.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects. There are 6 Groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 ~ S6 groups (of which 8 received study drugs and 2 received placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody by single subcutaneous injection with six different doses in healthy subjects. There are 6 groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 ~ S6 groups (of which 8 received study drugs and 2 received placebo). In each group, two subjects were sentinels (1 received the study drug and 1 placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
- Being tested
- 610, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
610Drug
Recombinant anti-IL-5 Humanized Monoclonal Antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 610 group | Experimental | Participants will be administered with 0.03mg/kg, 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg of 610 by subcutaneous injection. Subjects will be followed for 84 days. Receives: Drug: 610 |
| controll group | Placebo comparator | Participants will be administered with 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg placebo once by subcutaneous injection. Subjects will be followed for 84 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Plasma Concentration of 610
Measured: up to 84 days
Tmax
Time to Maximum Plasma Concentration of 610
Measured: up to 84 days
AUC
Area Under the Curve of 610
Measured: up to 84 days
t1/2
Half life of 610 in blood
Measured: up to 84 days
CL/F
Plasma clearance of 610
Measured: up to 84 days
Vd/F
Apparent Volume of Distribution of 610
Measured: up to 84 days
AE
To monitor adverse events (AEs) per the NCI CTCAE 5.0.
Measured: up to 84 days
Secondary outcomes (2)
Immunogenicity
Percentage of ADA positive and determination of ADA titer as well as Nab
Measured: up to 84 days
EOS
Compare the changes of EOS levels with the baseline
Measured: up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start12 Jun 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for add-on Maintenance Treatment of Patients With Severe Eosinophilic AsthmaStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) 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
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xueying Ding, D.M., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445038
- Sponsor's protocol ID
- SSGJ-610-HH-I-01
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-5 Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04445038
- Acronym / sponsor ID
- SSGJ-610-HH-I-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 24 Jun 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.
This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects. There are 6 Groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 ~ S6 groups (of which 8 received study drugs and 2 received placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
Detailed description
This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody by single subcutaneous injection with six different doses in healthy subjects. There are 6 groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 ~ S6 groups (of which 8 received study drugs and 2 received placebo). In each group, two subjects were sentinels (1 received the study drug and 1 placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 610 group | Experimental | Drug: 610Participants will be administered with 0.03mg/kg, 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg of 610 by subcutaneous injection. Subjects will be followed for 84 days. |
| controll group | Placebo comparator | Drug: PlaceboParticipants will be administered with 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg placebo once by subcutaneous injection. Subjects will be followed for 84 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese healthy participants, male or female, aged 18 to 55 (including both ends)
- The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
- Male participants and their partners or female participants must agree to take one or more non-drug contraceptives (such as complete abstinence, contraceptive rings, partner ligation, etc.) , and there is no sperm donation or egg donation plan
- Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
- Participants could communicate well with the researchers and compliance with the trial
Key exclusion criteria (17 listed)
- Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies, and with allergies (multiple drugs and food allergies)
- Subjects who have or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other that can interfere with the study results
- Those who have undergone surgery within the 3 months prior to the trial that will affect the absorption, distribution, metabolism, and excretion of the drug; or those who have undergone surgery within 4 weeks prior to the trial, or plan to undergo surgery during the study
- Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
- Alcoholics or frequent drinkers within 6 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine), or couldn't prohibit alcohol during the trial or alcohol breath test results greater than 0.0 mg / 100 mL
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 |
|---|---|---|
| 610Recombinant anti-IL-5 Humanized Monoclonal Antibody | Drug | 610 group |
| PlaceboPlacebo | Drug | controll group |
Primary outcome
Cmax
Time frame: up to 84 days
Maximum Plasma Concentration of 610
Tmax
Time frame: up to 84 days
Time to Maximum Plasma Concentration of 610
AUC
Time frame: up to 84 days
Area Under the Curve of 610
t1/2
Time frame: up to 84 days
Half life of 610 in blood
CL/F
Time frame: up to 84 days
Plasma clearance of 610
Vd/F
Time frame: up to 84 days
Apparent Volume of Distribution of 610
AE
Time frame: up to 84 days
To monitor adverse events (AEs) per the NCI CTCAE 5.0.
2 secondary outcomes
Immunogenicity
Time frame: up to 84 days
EOS
Time frame: up to 84 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: Undecided
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.
Xueying Ding, D.M. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 610 in people with add-on Maintenance Treatment of Patients With Severe Eosinophilic Asthma, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
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 17 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: status not confirmed, as of the sponsor's last update on 28 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Chou, B.M. (13701756821, 13701756821@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to 84 days). The study lists 7 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 28 Jan 2021.