CClinicalTrials.gg
CompletedNCT05421923Updated Nov 29, 2024

The Pharmacokinetics (PK), Pharmacodynamics(PD), Safety, Tolerability of SR1375 in Healthy Volunteers

A Phase 1 interventional study of SR1375 capsules and Placebo in Healthy, sponsored by Shanghai SIMR Biotechnology Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.

Sponsored by Shanghai SIMR Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled phase I bridging study to evaluate the PK, PD, safety and tolerability of SR1375 in healthy subjects.

Read the detailed description

The study is a Phase I study to evaluate the PK, PD, safety, and tolerability of SR1375 in healthy volunteers. The study will include 3 single-ascending-dose (SAD) cohorts and 1 multiple-dose cohorts (Part A and part B respectively), a total of 4 cohorts, and each cohort includes 3 stages: screening and baseline, treatment and safety monitoring, and safety follow-up.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Shanghai SIMR Biotechnology Co., Ltd. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy males and females who are 18 to 45 years of age.
  2. Based on medical history, physical examination, laboratory examination, chest CT scan, abdominal B-ultrasound, vital signs and ECG, the investigator considered that the results were normal or abnormal but no clinical significance.
  3. Bodyweight of male > 50 kg, Bodyweight of female > 45 kg and body mass index (BMI) between 18 and 28 kg/m2.
  4. Male subjects must agree to use a highly effective contraceptive method from signing the consent form until at least 90 days after the last dose of study drug, and must be willing not to donate sperm.
  5. Healthy female volunteers must be:

    i. Of non-childbearing potential(with a documented tubal ligation, bilateral salpingectomy, hysterectomy, or menopause for more than 1 year) ii. Of childbearing potential, must have a negative pregnancy test at the screening visit (blood test), must agree to use a highly effective contraceptive method from signing the consent form until at least 30 days after the last dose of study drug.

  6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion criteria

Exclusion Criteria:

  1. History of hypercoagulable state or history of thrombosis.
  2. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
  3. 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.
  4. History of asthma (excluding resolved childhood asthma), severe allergic responses.
  5. History of significant drug abuse within one year of screening.
  6. Except for topical (no significant systemic exposure) permitted, use of the following combination agents will be excluded:

    1. Use of prescription drugs within 14 days prior to initial administration, or within 7 days or five 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 abelling).
    2. Use the health supplement 7 days or 5 half-life before the first administration of the investigational drug.
    3. Use of depot injection or subcutaneous implantation drugs within 3 months prior to the first study drug administration.
    4. Received vaccine within 1 month prior to the first administration of the investigational drug.
  7. A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody or treponema pallidum antibody.
  8. A positive drug/alcohol result.
  9. History of regular alcohol consumption within 6 months of screening defined as:

    an average weekly intake of >14 units (1 unit of alcohol ≈360 mL beer or 45 mL 40% alcohol spirits or 150 mL wine), or abstain from alcohol during the study.

  10. Within 6 months of screening, smoking more than 5 cigarettes(including e- cigarettes).
  11. Donation or lost in excess of 400 mL of blood within 2 months of Day 1 or donation of plasma within 14 days of Day 1.
  12. The subject has participated in a clinical trial within 3 months of receiving IMP.
  13. 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.
  14. Breast-feeding and/or lactating subject.
  15. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    SR1375 capsules

    Ascending single and multiple doses of SR1375 orally

    Drug: SR1375 capsules

  • Placebo comparator
    Placebo

    Ascending single and multiple doses of SR1375 placebo orally

    Other: Placebo

Interventions

  • DrugSR1375 capsules

    Ascending single and multiple doses of SR1375 orally

  • OtherPlacebo

    Ascending single and multiple doses of Placebo orally

06

What researchers measure

Primary outcomes

  1. Cmax

    Peak plasma concentration

    Time frame: On scheduled intervals from Day 1 up to Day 54

  2. Tmax

    Time of peak plasma concentration

    Time frame: On scheduled intervals from Day 1 up to Day 54

  3. AUC

    Area under the plasma concentration-time curve

    Time frame: On scheduled intervals from Day 1 up to Day 54

  4. CL/F

    Apparent oral clearance

    Time frame: On scheduled intervals from Day 1 up to Day 54

  5. t1/2

    Terminal half-life

    Time frame: On scheduled intervals from Day 1 up to Day 54

  6. Rac

    Accumulation ratio

    Time frame: On scheduled intervals from Day 1 up to Day 54

Secondary outcomes

  1. The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR1375 capsules

    AE: Adverse Event

    Time frame: On scheduled intervals from Day 1 up to Day 54

  2. PAF-AH

    Platelet activating factor acetylhydrolase

    Time frame: On scheduled intervals from Day 1 up to Day 54

07

Study locations

1 site
  • Phase I clinical laboratory of Huashan Hospital
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05421923
Lead sponsor
Shanghai SIMR Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Jun 16, 2022
Start date
Jun 24, 2022
Primary completion
Oct 5, 2022
Completion
Oct 5, 2022
Last update
Nov 29, 2024

Study contacts

Zhang Jing
principal investigator · Phase I clinical laboratory of Huashan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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