The Pharmacokinetics (PK), Safety, Tolerability of SR419 in Healthy Volunteers

NCT05012761 | Completed Phase 1

• 1 other identifier: SR419-104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled phase I PK bridging study to evaluate the PK, safety and tolerability of SR419 in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Cmax

  Peak plasma concentration

  Up to Day 7

• Tmax

  Time of peak plasma concentration

  Up to Day 7

• AUC

  Area under the plasma concentration-time curve

  Up to Day 7

• CL/F

  Apparent oral clearance

  Up to Day 7

• t1/2

  Terminal half-life

  Up to Day 7

• Rac

  Accumulation ratio

  Up to Day 7

Secondary Outcomes (1)

• The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR419 capsules

  Up to Day12(+7 days) for the safety follow up since Day1

Study Arms (2)

SR419 capsules

EXPERIMENTAL

Ascending single and multiple doses of SR419 orally

Drug: SR419 capsules

Placebo

PLACEBO COMPARATOR

Ascending single and multiple doses of SR419 placebo orally

Drug: Placebo

Interventions

SR419 capsules DRUG

Ascending single and multiple doses of SR419 orally

SR419 capsules

Placebo DRUG

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

You may not qualify if:

• Clinically significant history of central nervous system (CNS) disease, such as cognitive disorder and seizures. History of non-clinically significant mild anxiety (related to social stressors) or situational sleep disturbance \> 6 months ago could be enrolled under the discretion of the Investigators.
• Known history of renal dysfunction or creatinine clearance \< 90 mL/min (calculated using the Cockcroft-Gault formula) at Screening.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities.
• 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.
• 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.
• 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 hypercoagulable state or history of thrombosis.
• A positive Hepatitis B surface antigen, positive Hepatitis C antibody and positive test for human immunodeficiency virus (HIV) antibody.
• within 6 months of screening, Smoking more than 4 cigarettes per day (including e-cigarettes).
• A positive drug/alcohol result at Screening or Day -1.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Shanghai SIMR Biotechnology Co., Ltd.: lead

Study Sites (1)

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

Shanghai, China

Location

Study Officials

• Chen Yu

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

  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: August 17, 2021
• First Posted: August 19, 2021
• Study Start: August 24, 2021
• Primary Completion: December 27, 2021
• Study Completion: May 27, 2022
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)