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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05753033
• Other study ID #: SR750-102
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2023
• Est. completion date: September 6, 2023

Study information

• Verified date: February 2023
• Source: Shanghai SIMR Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 6, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SR750 tablet
Ascending single and multiple doses of SR750 orally
• Placebo
Ascending single and multiple doses of placebo orally

Locations

Country	Name	City	State
China	Shanghai Clinical Research Center Phase I Clinical Research Unit (SCRC-PCRU)	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai SIMR Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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