A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375

A Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of SR1375 in Healthy Volunteers

This is a randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: SR1375; Drug: Matching placebo

Detailed Description

This study is a phase 1,randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers. The study is divided into two parts, Part A (single ascending dose [SAD]) and Part B (multiple ascending dose [MAD]). In Part A, the scheduled dose cohorts include 1, 3, 10, 30, 100, and 200 mg; in Part B, the planned dose range will be 5, 15, and 50 mg.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Healthy volunteers will be included in the study if they satisfy all the following criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Adult males (for both SAD and MAD stage) and female (only for MAD stage), 18 to 55 years of age (inclusive) at screening.
3. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2, with a body weight ≥ 50 kg at screening.
4. Use of tobacco or nicotine-containing products:
5. Medically healthy without clinically significant abnormalities at the screening visit, at check-in on Day -1 and pre-dose on Day 1.
6. Conventional 12-lead ECG recording in triplicate (the mean of triplicate measurements will be used to determine eligibility at the screening visit, on Day -1 and pre-dose on Day 1) consistent with normal cardiac conduction and function.
7. Have suitable venous access for blood sampling.
8. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Exclusion Criteria:

Volunteers will be excluded from the study if there is evidence of any of the following:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past three months determined by the Investigator to be clinically relevant.
2. Any history of malignant disease in the last 10 years (excluding completely treated cutaneous squamous cell or basal cell carcinoma).
3. Liver function test results (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT], and gamma glutamyl transferase [GGT]) and bilirubin (total, conjugated and unconjugated) elevated more than 1.5-fold above the upper limit of normal (ULN).
4. Positive test results for active human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
5. Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Exception: cholecystectomy is allowed.
6. History of substance abuse or alcohol abuse defined as >21 units of alcohol per week for males and >14 units of alcohol per week for females (for MAD cohorts only). 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.
7. Is an employee of an Investigator or Sponsor or an immediate relative of an Investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SR1375 Capsule; Ascending single and multiple doses of SR1375 capsules orally	Drug: SR1375; The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water
Experimental: Matching placebo; Ascending single and multiple doses of placebo capsules orally	Drug: Matching placebo; The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE (Adverse Event)	Incidence, type and severity and causality of AEs (including withdrawals due to safety or tolerability reasons)	Up to Day 32

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma PK : Tmax	Plasma PK : Time to Cmax (Tmax)	Up to Day 32
Plasma PK : Ctrough	Plasma PK : Trough concentrations (Ctrough) (Part B only)	Up to Day 32
Plasma PK : AUC0-t	Plasma PK : Area under the concentration-time curve from 0 to time of last quantifiable	Up to Day 32
Plasma PK : AUC0-∞	Plasma PK : Area under the concentration-time curve from t=0 to infinity (AUC0-∞)	Up to Day 32
Urine PK: Ae	Urine PK: Cumulative amount of unchanged drug excreted in urine (Ae)	Up to Day 4
Urine PK: CLr	Urine PK: Renal clearance (CLr)	Up to Day 4

Collaborators and Investigators

• Sponsor: Shanghai SIMR Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Andrew Redfern, Linear Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SR1375-101

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
• product manufactured in and exported from the U.S.: No