The Pharmacokinetics (PK), Safety, Tolerability of SR750 in Healthy Volunteers

A Phase I Bridging Study to Evaluate the PK, Safety and Tolerability of SR750 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR750 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: SR750 tablet

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tina Zhao; Phone Number: +862161161537; Email: contact@simrbio.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 X-ray, 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 and28 kg/m2
4. Male subjects must agree to use contraception methods.
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. Known history of renal dysfunction or creatinine clearance < 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
2. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
3. 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.
4. 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.
5. 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.
6. History of asthma (excluding resolved childhood asthma), severe allergic responses.
7. History of hypercoagulable state or history of thrombosis.
8. A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
9. Within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
10. A positive drug/alcohol result at Screening or Day -1.
11. 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.

12. 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.

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. Female subjects with positive pregnancy test results.
15. The investigator will determine any conditions in which subjects are not suitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Ascending single and multiple doses of placebo orally	Drug: Placebo; Ascending single and multiple doses of placebo orally
Experimental: SR750 tablet; Ascending single and multiple doses of SR750 orally	Drug: SR750 tablet; Ascending single and multiple doses of SR750 orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak plasma concentration	Up to Day 9
Tmax	Time of peak plasma concentration	Up to Day 9
AUC	Area under the plasma concentration-time curve	Up to Day 9
t1/2	Terminal half-life	Up to Day 9
CL/F	Apparent oral clearance	Up to Day 9
Rac	Accumulation ratio	Up to Day 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE: Adverse Event	The frequency and severity of althy volunteers administrated with single and repeated oral doses of SR750 AEs	Up to Day14(+7 days) for the safety follow up since Day1

Collaborators and Investigators

• Sponsor: Shanghai SIMR Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Chen Yu, Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SR750-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No