HealthyPhase 1NCT04527718
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
A Phase 1 study testing 611 in people with Healthy, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in United States.
Trial summary
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 611
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 13 Aug 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
- Able to understand and willing to sign the ICF
- Healthy male and female subjects, non-smokers, 18-55 years of age
- In the opinion of the investigator, with no significant medical history, and in good health.
- Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Subjects are able to follow the study protocol and complete the trial.
Who cannot join
- History of hypersensitivity to similar drugs to 611 or their excipients.
- Pregnant, or nursing females.
- HepBsAg or HepCAb positive.
- Human immunodeficiency virus (HIV) positive.
- Positive urine drug screen, or cotinine test.
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Dallas Clinical Research Unit
Dallas, Texas, 75247
About this study
Official title: A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.
Read the detailed description
Total duration of the study period per subject is about 4 months broken down as follows:
The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).
- Conditions
- Healthy
- Being tested
- Placebo, 611
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo as a single SC injection on Day 1;
611Drug
611 as a single SC injection on Day 1;
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 611 dose 1 (45mg) plus placebo Receives: Drug: Placebo; Drug: 611 |
| Cohort 2 | Experimental | 611 dose 2 (150mg) plus placebo Receives: Drug: Placebo; Drug: 611 |
| Cohort 3 | Experimental | 611 dose 3 (300mg) plus placebo Receives: Drug: Placebo; Drug: 611 |
| Cohort 4 | Experimental | 611 dose 4 (450mg) plus placebo Receives: Drug: Placebo; Drug: 611 |
| Cohort 5 | Experimental | 611 dose 5 (600mg) plus placebo Receives: Drug: Placebo; Drug: 611 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With TEAEs
Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
Measured: up to 71days (90 days for Cohorts 1 and 2)
Secondary outcomes (2)
PK
PK parameters not limit to Cmax
Measured: up to 71days (90 days for Cohorts 1 and 2)
Incidence of immunogenicity
ADA, and NAbs if ADA is positive
Measured: up to 71days (90 days for Cohorts 1 and 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start9 Sep 2020
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527718
- Sponsor's protocol ID
- SSGJ-611-HV-I-A
- Status last verified
- Nov 2022
- First submitted
- 16 Jul 2020
- Last updated
- 10 Nov 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 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT04527718
- Acronym / sponsor ID
- SSGJ-611-HV-I-A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 26 Aug 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 is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.
Detailed description
Total duration of the study period per subject is about 4 months broken down as follows:
The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Placebo, Drug: 611611 dose 1 (45mg) plus placebo |
| Cohort 2 | Experimental | Drug: Placebo, Drug: 611611 dose 2 (150mg) plus placebo |
| Cohort 3 | Experimental | Drug: Placebo, Drug: 611611 dose 3 (300mg) plus placebo |
| Cohort 4 | Experimental | Drug: Placebo, Drug: 611611 dose 4 (450mg) plus placebo |
| Cohort 5 | Experimental | Drug: Placebo, Drug: 611611 dose 5 (600mg) plus placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to understand and willing to sign the ICF
- Healthy male and female subjects, non-smokers, 18-55 years of age
- In the opinion of the investigator, with no significant medical history, and in good health.
- Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Subjects are able to follow the study protocol and complete the trial.
Key exclusion criteria (6 listed)
- History of hypersensitivity to similar drugs to 611 or their excipients.
- Pregnant, or nursing females.
- HepBsAg or HepCAb positive.
- Human immunodeficiency virus (HIV) positive.
- Positive urine drug screen, or cotinine test.
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 |
|---|---|---|
| Placeboplacebo as a single SC injection on Day 1; | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| 611611 as a single SC injection on Day 1; | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Percentage of Participants With TEAEs
Time frame: up to 71days (90 days for Cohorts 1 and 2)
Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
2 secondary outcomes
PK
Time frame: up to 71days (90 days for Cohorts 1 and 2)
Incidence of immunogenicity
Time frame: up to 71days (90 days for Cohorts 1 and 2)
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 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 611 in people with Healthy, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. 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 6 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 Nov 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?
Percentage of Participants With TEAEs (time frame: up to 71days (90 days for Cohorts 1 and 2)). 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 10 Nov 2022.