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

NCT05421923 | Completed Phase 1

• 1 other identifier: SR1375-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Cmax

  Peak plasma concentration

  On scheduled intervals from Day 1 up to Day 54

• Tmax

  Time of peak plasma concentration

  On scheduled intervals from Day 1 up to Day 54

• AUC

  Area under the plasma concentration-time curve

  On scheduled intervals from Day 1 up to Day 54

• CL/F

  Apparent oral clearance

  On scheduled intervals from Day 1 up to Day 54

• t1/2

  Terminal half-life

  On scheduled intervals from Day 1 up to Day 54

• Rac

  Accumulation ratio

  On scheduled intervals from Day 1 up to Day 54

Secondary Outcomes (2)

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

  On scheduled intervals from Day 1 up to Day 54

• PAF-AH

  On scheduled intervals from Day 1 up to Day 54

Study Arms (2)

SR1375 capsules

EXPERIMENTAL

Ascending single and multiple doses of SR1375 orally

Drug: SR1375 capsules

Placebo

PLACEBO COMPARATOR

Ascending single and multiple doses of SR1375 placebo orally

Other: Placebo

Interventions

SR1375 capsules DRUG

Ascending single and multiple doses of SR1375 orally

SR1375 capsules

Placebo OTHER

Ascending single and multiple doses of Placebo orally

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females who are 18 to 45 years of age.
• 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.
• Bodyweight of male \> 50 kg, Bodyweight of female \> 45 kg and body mass index (BMI) between 18 and 28 kg/m2.
• 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.
• 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.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

• History of hypercoagulable state or history of thrombosis.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities.
• 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.
• History of asthma (excluding resolved childhood asthma), severe allergic responses.
• History of significant drug abuse within one year of screening.
• Except for topical (no significant systemic exposure) permitted, use of the following combination agents will be excluded:
• 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).
• Use the health supplement 7 days or 5 half-life before the first administration of the investigational drug.
• Use of depot injection or subcutaneous implantation drugs within 3 months prior to the first study drug administration.
• Received vaccine within 1 month prior to the first administration of the investigational drug.
• A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody or treponema pallidum antibody.
• A positive drug/alcohol result.
• 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.
• Within 6 months of screening, smoking more than 5 cigarettes(including e- cigarettes).

Sponsors & Collaborators

• Shanghai SIMR Biotechnology Co., Ltd.: lead

Study Sites (1)

Phase I clinical laboratory of Huashan Hospital

Shanghai, China

Location

Study Officials

• Zhang Jing

  Phase I clinical laboratory of Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 16, 2022
• Study Start: June 24, 2022
• Primary Completion: October 5, 2022
• Study Completion: October 5, 2022
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)