Healthy VolunteersPhase 1NCT05083468
The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers
A Phase 1 study testing SR750 tablet in people with Healthy Volunteers, run by Shanghai SIMR Biotechnology Co., Ltd. at 1 site in Australia.
Trial summary
This study is to evaluate the safety, tolerability, and PK of SR750 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 Volunteers
- What is being tested?
- SR750 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Oct 2021to 14 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers will be included in the study if they satisfy all the following criteria:
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Adult males and females, 18 to 55 years of age (inclusive) at Screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg for males or ≥ 45 kg for females at screening.
- Use of tobacco or nicotine-containing products:
- Have less than 10 tobacco or nicotine-containing products (including tobacco, e-cigarettes) per week in the last 3 months prior to dosing; abstain from smoking from 7 days prior to dosing until the final follow-up visit;
Show all 28Show fewer
- Have not used any marijuana in the 3 months prior to screening until the end of study.
- Medically healthy without clinically significant abnormalities at the screening visit, at check-in on Day -1, and pre-dose on Day 1, including:
- Physical examination without any clinically relevant findings;
- Systolic blood pressure in the range of 90 to 140 mmHg (inclusive) and diastolic blood pressure in the range of 40 to 90 mmHg (inclusive) after 5 minutes in supine position;
- Pulse rate in the range of 60 to 100 bpm, inclusive (40-60 bpm [inclusive] may be considered acceptable for athletes or volunteers without clinical significance at the discretion of the PI or designee) after 5 minutes rest in supine position;
- Body temperature (tympanic), between 35.5°C and 37.5°C (inclusive);
- No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests as judged by the Investigator.
- Conventional 12-lead Electrocardiogram (ECG) recording in triplicate (the mean of triplicate measurements will be used to determine eligibility at the screening visit, on Day 1 and pre-dose on Day 1) consistent with normal cardiac conduction and function, including:
- T interval corrected using the Fridericia method (QTcF) ≤ 450 msec for males, and ≤ 470 msec for females;
- QRS (wave group of Q, R and S in ECG) duration of ≤ 120 msec;
- Electrocardiogram morphology consistent with healthy cardiac ventricular conduction and normal rhythm, and with measurement of the QT interval;
- No family history of short or long QT syndrome, or sudden cardiac death;
- No history of torsade de pointes or a known arrhythmia.
- Healthy female volunteers must:
- Of non-childbearing potential, defined as: i. Pre-menopausal females with a documented tubal ligation, tubal occlusion procedure followed by a hysterosalpingogram that confirmed bilateral tubal occlusion, bilateral salpingectomy, hysterectomy, bilateral oophorectomy, or other documented medical conditions which cause infertility and are considered to be of non-childbearing potential; Note: "documented" refers to the outcome of the Investigator's/designee's review of the healthy volunteer's medical history for study eligibility, as obtained via a verbal interview with the healthy volunteer or from the healthy volunteer's medical records).
- Postmenopausal, defined as a minimum of 12 months of spontaneous amenorrhea (in questionable cases a blood sample with follicle stimulating hormone [FSH] >40 Million International Units (mIU)/mL is confirmatory).
- If of childbearing potential, must have a negative pregnancy test at the screening visit (blood test) and before the first study drug administration (Day -1 urine test). They must agree not to attempt to become pregnant, must not be breastfeeding, must not donate ova from signing the consent form until at least 30 days after the last does of study drug, and must agree to: i. Use 2 forms of highly effective contraceptive method at least 2 weeks prior to screening, between signing consent, during the study, and at least 30 days after the last dose of study therapy, OR ii. Use at least one highly effective contraceptive method, plus an additional barrier-method of contraception at least 2 weeks prior to screening, between signing the consent, during the study, and at least 30 days after the last dose of study drug. Acceptable barrier methods include: female diaphragm condom usage for male partner, OR iii. True abstinence condition at least 2 weeks prior to screening, between signing consent, during the study, and at least 30 days after the last dose of study therapy.
- Women of childbearing potential (WOCBP) with solely same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
- Male healthy volunteers, if not surgically sterilised (defined as performed at least 3 months prior to the first dose which could be confirmed by the documentation or verbal interview), must be willing not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must be willing to use a condom in addition to having the female partner use a highly effective contraceptive method from signing the consent form until at least 90 days after the last dose of study drug. If engaging in sexual intercourse with a pregnant partner, must be willing to use a barrier-method of contraception. Male healthy volunteers with same-sex partner (abstinence from penile-vaginal intercourse) and male healthy volunteers who are true abstinence are eligible when this is their preferred and usual lifestyle.
- Male participants must be willing to use a condom if engaging in sexual intercourse with a same sex partner from signing the consent form until study exit.
- Have suitable venous access for blood sampling.
- Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Who cannot join
- Volunteers will be excluded from the study if there is evidence of any of the following:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or significant neurological or psychiatric disease (including history of epilepsy or seizures), including any acute illness or major surgery within the past 3 months determined by the Investigator to be clinically relevant.
- Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications.
- Any history of malignant disease in the last 10 years (excludes completely treated cutaneous squamous cell or basal cell carcinoma).
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- Use of or having plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon, with the exception of topical steroid creams) during the study or within 3 months prior to the first study drug administration.
Show all 20Show fewer
- Liver function test results (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], and gamma glutamyl transferase [GGT]) and bilirubin (total, conjugated and unconjugated) elevated more than 1.2-fold above the upper limit of normal (ULN).
- Positive test results for active human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
- Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Estimated creatinine clearance (CrCl) < 80 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
- Regular use of substance abuse or alcohol abuse within 3 months prior to Screening, where "regular" is defined as >21 units of alcohol per week for males and >14 units of alcohol per week 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.
- Positive drug or alcohol test results at the screening visit or at check-in (Day -1) (may be repeated once, if a positive test was recorded in the first instance, at the discretion of the PI or designee).
- Use of any systemically absorbed prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 × half-lives of the medication (whichever is longer) prior to the first study drug administration, except occasional use of paracetamol (up to a maximum of 2000 mg per day of paracetamol and per local or national labelling) or hormonal contraceptives.
- History of demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would increase the risk of having allergic reactions associated with investigational product administration.
- Known hypersensitivity to any of the study drug ingredients.
- Use of any vaccinations within 7 days prior to the first study drug administration, or plan to use any vaccinations within 2 weeks after the last dose.
- Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of first study drug administration.
- The healthy volunteer has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
- Is an employee of an Investigator or Sponsor or an immediate relative of an investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SR750 in Healthy Volunteers
This study is to evaluate the safety, tolerability, and PK of SR750 in healthy volunteers.
Read the detailed description
This study is a randomized, double-blinded, placebo-controlled, 2-part Phase I study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of SR750 in healthy volunteers. This study includes 2 parts:
Part A is a double-blind, randomized, placebo-controlled, single-dose escalation study of SR750 in healthy volunteers.
Part B is a double-blind, randomized, placebo-controlled, repeated-dose escalation study of SR750 in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- SR750 tablet, matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR750 tabletDrug
The volunteers will be orally administrated by single or multiple dose of SR750 tablet with 240 mL water.
matching placeboDrug
The volunteers will be orally administrated by single or multiple dose of matching placebo with 240 mL water.
| Study group | Role | What they receive |
|---|---|---|
| SR750 tablet | Experimental | Ascending single and multiple doses of SR750 tablets orally Receives: Drug: SR750 tablet |
| matching placebo | Placebo comparator | Ascending single and multiple doses of matching placebo orally Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR750
AE: adverse event
Measured: Up to Day15 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 Oct 2021
- Study start29 Oct 2021
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai SIMR Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cameron Johnson, Study director, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083468
- Sponsor's protocol ID
- SR750-101
- Status last verified
- Nov 2024
- First submitted
- 27 Sep 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 Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SR750 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05083468
- Acronym / sponsor ID
- SR750-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Shanghai SIMR Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 19 Oct 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 study is to evaluate the safety, tolerability, and PK of SR750 in healthy volunteers.
Detailed description
This study is a randomized, double-blinded, placebo-controlled, 2-part Phase I study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of SR750 in healthy volunteers. This study includes 2 parts:
Part A is a double-blind, randomized, placebo-controlled, single-dose escalation study of SR750 in healthy volunteers.
Part B is a double-blind, randomized, placebo-controlled, repeated-dose escalation study of SR750 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR750 tablet | Experimental | Drug: SR750 tabletAscending single and multiple doses of SR750 tablets orally |
| matching placebo | Placebo comparator | Drug: matching placeboAscending single and multiple doses of matching placebo orally |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (28 listed)
- Healthy volunteers will be included in the study if they satisfy all the following criteria:
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- Adult males and females, 18 to 55 years of age (inclusive) at Screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg for males or ≥ 45 kg for females at screening.
- Use of tobacco or nicotine-containing products:
Key exclusion criteria (20 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or significant neurological or psychiatric disease (including history of epilepsy or seizures), including any acute illness or major surgery within the past 3 months determined by the Investigator to be clinically relevant.
- Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications.
- Any history of malignant disease in the last 10 years (excludes completely treated cutaneous squamous cell or basal cell carcinoma).
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
- Use of or having plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon, with the exception of topical steroid creams) during the study or within 3 months prior to the first study drug administration.
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 |
|---|---|---|
| SR750 tabletThe volunteers will be orally administrated by single or multiple dose of SR750 tablet with 240 mL water. | Drug | SR750 tablet |
| matching placeboThe volunteers will be orally administrated by single or multiple dose of matching placebo with 240 mL water. | Drug | matching placebo |
Primary outcome
The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR750
Time frame: Up to Day15 for the safety follow up since Day1
AE: adverse event
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
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Cameron Johnson study director
Nucleus Network Pty Ltd.
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 SR750 tablet in people with Healthy Volunteers, run by Shanghai SIMR Biotechnology Co., Ltd. at 1 site in Australia.
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 28 inclusion and 20 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 Australia. 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?
The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR750 (time frame: Up to Day15 for the safety follow up since Day1). 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.