HealthyPhase 1NCT03917628
Pharmacokinetics and Safety in Healthy Volunteers
A Phase 1 study testing SCT630 and adalimumab-EU source in people with Healthy, run by Sinocelltech Ltd. at 1 site in China.
Trial summary
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SCT630 and adalimumab-EU source
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2019to 4 Nov 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects aged 18 to 45 years
- Body mass index (BMI) between 19 and 26 kg/m2
- Normal or clinically acceptable physical examination, clinical laboratory values, ECG, chest X-ray and vital signs at screening and baseline.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Who cannot join
- History or evidence of a clinically significant disorder, condition, or disease that would have posed a risk to subject safety or would have interfered with the study evaluation, procedures, or study completion in the opinion of the investigator.
- Evidence of any bacterial, viral, parasitic, systemic fungal infections, or infections due to other opportunistic pathogens within the 30 days prior to investigational product administration.
- History of tuberculosis,positive test for Interferon-gamma-release assay,or suffering from active tuberculosis or latent tuberculosis infection.
- History of malignancy of any type, other than surgically excised nonmelanomatous skin cancers, within 5 years prior to investigational product administration.
- Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening.
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients).
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- Quantification of Hepatitis B virus DNA is greater than the upper limit of normal value.
- Received biologics or live vaccines ≤3 months prior to investigational product administration.
- Intake of an investigational drug in another trial within three months prior to investigational product administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Safety of SCT630 in Healthy Subjects: a Randomized, Double-blind, Single Dose Clinical Phase I Study.
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.
- Conditions
- Healthy
- Being tested
- SCT630, adalimumab-EU source
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCT630Drug
SCT630 single s.c. injection
adalimumab-EU sourceDrug
adalimumab-EU source single s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| SCT630 | Experimental | Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing SCT630 Receives: Drug: SCT630 |
| adalimumab-EU source | Active comparator | Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source Receives: Drug: adalimumab-EU source |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-tz
Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of SCT630 and EU-licensed Humira
Measured: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Cmax
Maximum Concentration (Cmax) of SCT630 and EU-licensed Humira
Measured: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Secondary outcomes (8)
AUC 0-∞
Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of SCT630 and EU-licensed Humira
Measured: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Tmax
Time to the Maximum Concentration of SCT630 and EU-licensed Humira
Measured: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
t1/2
Elimination Phase Half-life of SCT630 and EU-licensed Humira
Measured: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
λz
λz of SCT630 and EU-licensed Humira
Measured: Day 1 through Day 71
CL
Clearance rate of the SCT630 and EU-licensed Humira
Measured: Day 1 through Day 71
Vd
Apparent volume of distribution (Vd) of the SCT630 and EU-licensed Humira
Measured: Day 1 through Day 71
Number (Proportion) of Subjects With Drug Related Adverse Events
Measured: Day 1 through Day 71
Positive rate of ADA and NAb
Comparision of the positive rate of ADA and NAb between the SCT630 and EU-licensed Humira
Measured: Day 1 through Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start29 May 2019
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
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 Sinocelltech 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917628
- Sponsor's protocol ID
- SCT630PS01
- Status last verified
- Jan 2021
- First submitted
- 14 Apr 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of SCT630 in Healthy Subjects: a Randomized, Double-blind, Single Dose Clinical Phase I Study.
- ClinicalTrials.gov ID
- NCT03917628
- Acronym / sponsor ID
- SCT630PS01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 17 Apr 2019 (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.
Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish pharmacokinetic similarity of SCT630 to adalimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCT630 | Experimental | Drug: SCT630Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing SCT630 |
| adalimumab-EU source | Active comparator | Drug: adalimumab-EU sourceSubject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing adalimumab-EU source |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male subjects aged 18 to 45 years
- Body mass index (BMI) between 19 and 26 kg/m2
- Normal or clinically acceptable physical examination, clinical laboratory values, ECG, chest X-ray and vital signs at screening and baseline.
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Key exclusion criteria (9 listed)
- History or evidence of a clinically significant disorder, condition, or disease that would have posed a risk to subject safety or would have interfered with the study evaluation, procedures, or study completion in the opinion of the investigator.
- Evidence of any bacterial, viral, parasitic, systemic fungal infections, or infections due to other opportunistic pathogens within the 30 days prior to investigational product administration.
- History of tuberculosis,positive test for Interferon-gamma-release assay,or suffering from active tuberculosis or latent tuberculosis infection.
- History of malignancy of any type, other than surgically excised nonmelanomatous skin cancers, within 5 years prior to investigational product administration.
- Positive test for HIV antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies at screening.
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 |
|---|---|---|
| SCT630SCT630 single s.c. injection | Drug | SCT630 |
| adalimumab-EU sourceadalimumab-EU source single s.c. injection | Drug | adalimumab-EU source |
Primary outcome
AUC0-tz
Time frame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of SCT630 and EU-licensed Humira
Cmax
Time frame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Maximum Concentration (Cmax) of SCT630 and EU-licensed Humira
8 secondary outcomes
AUC 0-∞
Time frame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
Tmax
Time frame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
t1/2
Time frame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.
λz
Time frame: Day 1 through Day 71
CL
Time frame: Day 1 through Day 71
Vd
Time frame: Day 1 through Day 71
Number (Proportion) of Subjects With Drug Related Adverse Events
Time frame: Day 1 through Day 71
Positive rate of ADA and NAb
Time frame: Day 1 through Day 71
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 29 Jan 2021.
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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 SCT630 and adalimumab-EU source in people with Healthy, run by Sinocelltech 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 4 inclusion and 9 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 29 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. 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?
AUC0-tz (time frame: at -1 hour (h) (pre dosing) and 8, 24, 48, 72, 96, 120, 144, 168, 192, 336, 504, 672, 840, 1008,1344 h post dosing and on day 71 post dosing.). 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 29 Jan 2021.