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

NCT ID: NCT05026008

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-03-30

Brief Summary

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

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SR1375 Capsule

Ascending single and multiple doses of SR1375 capsules orally

Group Type: EXPERIMENTAL

SR1375

Intervention Type: DRUG

The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water

Matching placebo

Ascending single and multiple doses of placebo capsules orally

Group Type: EXPERIMENTAL

Matching placebo

Intervention Type: DRUG

The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water

Interventions

SR1375

The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water

Intervention Type: DRUG

Matching placebo

The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai SIMR Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Redfern

Role: PRINCIPAL_INVESTIGATOR

Linear Clinical Research

Locations

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

SR1375-101

Identifier Type: -

Identifier Source: org_study_id