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

NCT05026008 | Completed Phase 1 DMC

• 1 other identifier: SR1375-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• AE (Adverse Event)

  Incidence, type and severity and causality of AEs (including withdrawals due to safety or tolerability reasons)

  Up to Day 32

Secondary Outcomes (6)

• Plasma PK : Tmax

  Up to Day 32

• Plasma PK : Ctrough

  Up to Day 32

• Plasma PK : AUC0-t

  Up to Day 32

• Plasma PK : AUC0-∞

  Up to Day 32

• Urine PK: Ae

  Up to Day 4

Study Arms (2)

SR1375 Capsule

EXPERIMENTAL

Ascending single and multiple doses of SR1375 capsules orally

Drug: SR1375

Matching placebo

EXPERIMENTAL

Ascending single and multiple doses of placebo capsules orally

Drug: Matching placebo

Interventions

SR1375 DRUG

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

SR1375 Capsule

Matching placebo DRUG

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

Matching placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers will be included in the study if they satisfy all the following criteria:
• 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.
• Adult males (for both SAD and MAD stage) and female (only for MAD stage), 18 to 55 years of age (inclusive) at screening.
• Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2, with a body weight ≥ 50 kg at screening.
• Use of tobacco or nicotine-containing products:
• Medically healthy without clinically significant abnormalities at the screening visit, at check-in on Day -1 and pre-dose on Day 1.
• 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.
• Have suitable venous access for blood sampling.
• Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

You may not qualify if:

• Volunteers will be excluded from the study if there is evidence of any of the following:
• 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.
• Any history of malignant disease in the last 10 years (excluding completely treated cutaneous squamous cell or basal cell carcinoma).
• 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).
• 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.
• 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.
• 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.
• Is an employee of an Investigator or Sponsor or an immediate relative of an Investigator.

Sponsors & Collaborators

• Shanghai SIMR Biotechnology Co., Ltd.: lead

Study Sites (1)

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

Location

Study Officials

• Andrew Redfern

  Linear Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 30, 2021
• Study Start: September 30, 2021
• Primary Completion: November 30, 2022
• Study Completion: March 30, 2023
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)