The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers

NCT05083468 | Completed Phase 1

• 1 other identifier: SR750-101
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety, tolerability, and PK of SR750 in healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The frequency and severity of AEs in healthy volunteers administrated with single and repeated oral doses of SR750

  AE: adverse event

  Up to Day15 for the safety follow up since Day1

Other Outcomes (8)

• Cmax

  Up to Day 10

• Tmax

  Up to Day 10

• Ctrough

  Up to Day 10

Study Arms (2)

SR750 tablet

EXPERIMENTAL

Ascending single and multiple doses of SR750 tablets orally

Drug: SR750 tablet

matching placebo

PLACEBO COMPARATOR

Ascending single and multiple doses of matching placebo orally

Drug: matching placebo

Interventions

SR750 tablet DRUG

The volunteers will be orally administrated by single or multiple dose of SR750 tablet with 240 mL water.

SR750 tablet

matching placebo DRUG

The volunteers will be orally administrated by single or multiple dose of matching placebo 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 and females, 18 to 55 years of age (inclusive) at Screening.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg for males or ≥ 45 kg for females at screening.
• Use of tobacco or nicotine-containing products:
• Have less than 10 tobacco or nicotine-containing products (including tobacco, e-cigarettes) per week in the last 3 months prior to dosing; abstain from smoking from 7 days prior to dosing until the final follow-up visit;
• Have not used any marijuana in the 3 months prior to screening until the end of study.
• Medically healthy without clinically significant abnormalities at the screening visit, at check-in on Day -1, and pre-dose on Day 1, including:
• Physical examination without any clinically relevant findings;
• Systolic blood pressure in the range of 90 to 140 mmHg (inclusive) and diastolic blood pressure in the range of 40 to 90 mmHg (inclusive) after 5 minutes in supine position;
• Pulse rate in the range of 60 to 100 bpm, inclusive (40-60 bpm \[inclusive\] may be considered acceptable for athletes or volunteers without clinical significance at the discretion of the PI or designee) after 5 minutes rest in supine position;
• Body temperature (tympanic), between 35.5°C and 37.5°C (inclusive);
• No clinically significant findings in serum chemistry, haematology, coagulation, and urinalysis tests as judged by the Investigator.
• Conventional 12-lead Electrocardiogram (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, including:
• T interval corrected using the Fridericia method (QTcF) ≤ 450 msec for males, and ≤ 470 msec for females;

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, hematological, gastrointestinal, endocrine, immunologic, dermatologic or significant neurological or psychiatric disease (including history of epilepsy or seizures), including any acute illness or major surgery within the past 3 months determined by the Investigator to be clinically relevant.
• Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications.
• Any history of malignant disease in the last 10 years (excludes completely treated cutaneous squamous cell or basal cell carcinoma).
• Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
• Use of or having plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon, with the exception of topical steroid creams) during the study or within 3 months prior to the first study drug administration.
• 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 1.2-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.
• Estimated creatinine clearance (CrCl) \< 80 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN.
• Regular use of substance abuse or alcohol abuse within 3 months prior to Screening, where "regular" is defined as \>21 units of alcohol per week for males and \>14 units of alcohol per week 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.
• Positive drug or alcohol test results at the screening visit or at check-in (Day -1) (may be repeated once, if a positive test was recorded in the first instance, at the discretion of the PI or designee).
• Use of any systemically absorbed prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 × half-lives of the medication (whichever is longer) prior to the first study drug administration, except occasional use of paracetamol (up to a maximum of 2000 mg per day of paracetamol and per local or national labelling) or hormonal contraceptives.
• History of demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the Investigator, would increase the risk of having allergic reactions associated with investigational product administration.
• Known hypersensitivity to any of the study drug ingredients.

Sponsors & Collaborators

• Shanghai SIMR Biotechnology Co., Ltd.: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Cameron Johnson

  Nucleus Network Pty Ltd.

  STUDY DIRECTOR

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: September 27, 2021
• First Posted: October 19, 2021
• Study Start: October 29, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)