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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05026008
• Other study ID #: SR1375-101
• Status: Completed
• Phase: Phase 1
• Start date: September 30, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: December 2022
• 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, 2-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SR1375 in healthy volunteers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• SR1375
The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water
• Matching placebo
The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water

Locations

Country	Name	City	State
Australia	Linear Clinical Research Ltd	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
SIMR (Australia) Biotech Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE (Adverse Event)	Incidence, type and severity and causality of AEs (including withdrawals due to safety or tolerability reasons)	Up to Day 32
Secondary	Plasma PK : Tmax	Plasma PK : Time to Cmax (Tmax)	Up to Day 32
Secondary	Plasma PK : Ctrough	Plasma PK : Trough concentrations (Ctrough) (Part B only)	Up to Day 32
Secondary	Plasma PK : AUC0-t	Plasma PK : Area under the concentration-time curve from 0 to time of last quantifiable	Up to Day 32
Secondary	Plasma PK : AUC0-8	Plasma PK : Area under the concentration-time curve from t=0 to infinity (AUC0-8)	Up to Day 32
Secondary	Urine PK: Ae	Urine PK: Cumulative amount of unchanged drug excreted in urine (Ae)	Up to Day 4
Secondary	Urine PK: CLr	Urine PK: Renal clearance (CLr)	Up to Day 4