HealthyPhase 1NCT05012761
The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers
A Phase 1 study testing SR419 capsules in people with Healthy, run by Shanghai SIMR Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR419 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SR419 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2021to 27 May 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females who are 18 to 45 years of age.
- Based on medical history, physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, vital signs and ECG, the investigator considered that the results were normal or abnormal but no clinical significance.
- Bodyweight of male > 50 kg, Bodyweight of female > 45 kg and body mass index (BMI) between 18 and28 kg/m2
- Male subjects must agree to use contraception methods.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Clinically significant history of central nervous system (CNS) disease, such as cognitive disorder and seizures. History of non-clinically significant mild anxiety (related to social stressors) or situational sleep disturbance > 6 months ago could be enrolled under the discretion of the Investigators.
- Known history of renal dysfunction or creatinine clearance < 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
- History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
- History of sensitivity to any of the investigational medicinal products (IMPs), or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
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- History of asthma (excluding resolved childhood asthma), severe allergic responses.
- History of hypercoagulable state or history of thrombosis.
- A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
- within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
- A positive drug/alcohol result at Screening or Day -1.
- Donation or lost in excess of 500 mL of blood within 56 days of Day 1 or donation of plasma within 14 days of Day 1.
- The subject has participated in a clinical trial within 3 months of receiving IMP.
- Use of medication other than topical products without significant systemic absorption.
- Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 24h prior to the first dose of IMP until the Safety Follow-up visit.
- Unable to refrain from consumption of alcohol, products containing caffeine or xanthine (such as coffee, tea, cola, chocolate) within 7 days prior to the first dose of IMP until the Safety Follow-up visit.
- Breast-feeding and/or lactating subject.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
Shanghai
About this study
Official title: A Phase I Bridging Study to Evaluate the PK, Safety and Tolerability of SR419 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR419 in healthy subjects.
Read the detailed description
The study is a Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 2 multiple-dose cohorts (Part A and part B respectively), a total of 5 cohorts, and each cohort includes 3 stages: screening and baseline, treatment and safety monitoring, and safety follow-up.
- Conditions
- Healthy
- Being tested
- SR419 capsules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR419 capsulesDrug
Ascending single and multiple doses of SR419 orally
PlaceboDrug
Ascending single and multiple doses of placebo orally
| Study group | Role | What they receive |
|---|---|---|
| SR419 capsules | Experimental | Ascending single and multiple doses of SR419 orally Receives: Drug: SR419 capsules |
| Placebo | Placebo comparator | Ascending single and multiple doses of SR419 placebo orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak plasma concentration
Measured: Up to Day 7
Tmax
Time of peak plasma concentration
Measured: Up to Day 7
AUC
Area under the plasma concentration-time curve
Measured: Up to Day 7
CL/F
Apparent oral clearance
Measured: Up to Day 7
t1/2
Terminal half-life
Measured: Up to Day 7
Rac
Accumulation ratio
Measured: Up to Day 7
Secondary outcomes (1)
The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR419 capsules
AE: Adverse Event
Measured: Up to Day12(+7 days) for the safety follow up since Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start24 Aug 2021
- Primary completion27 Dec 2021
- Study completion27 May 2022
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai SIMR Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Yu, Principal investigator, Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012761
- Sponsor's protocol ID
- SR419-104
- Status last verified
- Nov 2024
- First submitted
- 17 Aug 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Bridging Study to Evaluate the PK, Safety and Tolerability of SR419 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05012761
- Acronym / sponsor ID
- SR419-104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai SIMR Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 19 Aug 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.
This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR419 in healthy subjects.
Detailed description
The study is a Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 2 multiple-dose cohorts (Part A and part B respectively), a total of 5 cohorts, and each cohort includes 3 stages: screening and baseline, treatment and safety monitoring, and safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR419 capsules | Experimental | Drug: SR419 capsulesAscending single and multiple doses of SR419 orally |
| Placebo | Placebo comparator | Drug: PlaceboAscending single and multiple doses of SR419 placebo orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males and females who are 18 to 45 years of age.
- Based on medical history, physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, vital signs and ECG, the investigator considered that the results were normal or abnormal but no clinical significance.
- Bodyweight of male > 50 kg, Bodyweight of female > 45 kg and body mass index (BMI) between 18 and28 kg/m2
- Male subjects must agree to use contraception methods.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Key exclusion criteria (18 listed)
- Clinically significant history of central nervous system (CNS) disease, such as cognitive disorder and seizures. History of non-clinically significant mild anxiety (related to social stressors) or situational sleep disturbance > 6 months ago could be enrolled under the discretion of the Investigators.
- Known history of renal dysfunction or creatinine clearance < 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities.
- History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
- History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to 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 |
|---|---|---|
| SR419 capsulesAscending single and multiple doses of SR419 orally | Drug | SR419 capsules |
| PlaceboAscending single and multiple doses of placebo orally | Drug | Placebo |
Primary outcome
Cmax
Time frame: Up to Day 7
Peak plasma concentration
Tmax
Time frame: Up to Day 7
Time of peak plasma concentration
AUC
Time frame: Up to Day 7
Area under the plasma concentration-time curve
CL/F
Time frame: Up to Day 7
Apparent oral clearance
t1/2
Time frame: Up to Day 7
Terminal half-life
Rac
Time frame: Up to Day 7
Accumulation ratio
1 secondary outcome
The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR419 capsules
Time frame: Up to Day12(+7 days) for the safety follow up since Day1
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 Nov 2024.
- 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.
Chen Yu principal investigator
Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)
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 SR419 capsules in people with Healthy, run by Shanghai SIMR Biotechnology 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 18 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 Nov 2024. 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?
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?
Cmax (time frame: Up to Day 7). The study lists 6 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 Nov 2024.