A Phase 1 Study of SMP-100 in Normal Healthy Volunteers

NCT04296799 | Completed Phase 1 FDA Drug

• 1 other identifier: ChengduSciMount
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This will be the first clinical study of oral administration SMP-100 in healthy subjects. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single and multiple ascending dose study in approximately 72 healthy male and female subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Safety Endpoints of SAD

  Number of subjects with adverse events (AEs) (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead electrocardiogram (ECGs), clinical laboratory parameters, weight, and physical examination.

  10±2 days post dose

• Safety Endpoints of MAD

  Number of subjects with adverse events (AEs) (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead electrocardiogram (ECGs), clinical laboratory parameters, weight, and physical examination.

  13±2 days post last dose

Secondary Outcomes (23)

• PK Endpoints AUC0-t of SAD

  before dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose.

• PK Endpoints AUC0-24 of SAD

  before dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose.

• PK Endpoints AUC0 inf of SAD

  before dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose.

• PK Endpoints Cmax of SAD

  before dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose.

• PK Endpoints Tmax of SAD

  before dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose.

Study Arms (2)

Single Ascending Dose

EXPERIMENTAL

The study will consist of 6 cohorts (1 cohort per dose level) of 8 subjects (6 subjects receiving the study drug and 2 receiving matching placebo), for a total of 48 subjects.

Drug: SMP-100; Drug: Placebo

Multiple Ascending Dose

EXPERIMENTAL

The study will consist of 3 cohorts (1 cohort per dose level) of 8 subjects. Six subjects will receive study drug and 2 subjects will receive matching placebo, daily for 14 consecutive days, for a total of 24 subjects (18 study drug; 6 placebo).

Drug: SMP-100; Drug: Placebo

Interventions

SMP-100 DRUG

SAD/MAD

Also known as: SMP-100 oral solution, ALB-137391(a), CSTI-300

Multiple Ascending Dose; Single Ascending Dose

Placebo DRUG

Placebo

Also known as: Placebo oral solution

Multiple Ascending Dose; Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening) aged between ≥18 and ≤59 years old.
• BMI \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Healthy as defined by:
• the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• the absence of clinically significant history of constipation, diarrhea, or irregular bowel transit in the last 4 weeks.
• the absence of clinically significant history of irritable bowel syndrome (IBS) of any type.
• the absence of current or history of ischemic colitis.
• Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after (the last) study drug administration:
• simultaneous use of intra-uterine contraceptive device placed at least 4 weeks prior to (the first) study drug administration, and condom for the male partner;
• simultaneous use of hormonal contraceptive starting at least 4 weeks prior to (the first) study drug administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
• simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 21 days prior to (the first) study drug administration.
• A woman is considered of childbearing potential unless she is surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before screening or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause).
• Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
• simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks or intra-uterine contraceptive device placed since at least 4 weeks;

You may not qualify if:

• Any clinically significant abnormality at physical examination.
• Any clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
• Positive urine drug screen, alcohol breath test, or urine cotinine test at screening. A repeat test can be conducted at screening or Day -1 at the discretion of the Principal Investigator or delegate.
• History of allergic reactions to SMP-100 or other related drugs, or to any excipient in the formulation.
• History of hypersensitivity to 5-HT3 receptor antagonists or agonists.
• Positive serum pregnancy test at screening.
• Clinically significant ECG abnormalities (QTcF \>450 ms for males and QTcF \>460 ms for females).
• Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 159 mmHg, diastolic blood pressure lower than 50 or over 100 mmHg, or heart rate less than 50 or over 100 bpm) at screening. Repeat test can be conducted at screening or Day -1 at the discretion of the Principal Investigator or delegate.
• Clinically significant orthostatic vital sign abnormalities such as decrease in systolic blood pressure of 20 mmHg or higher, decrease in diastolic blood pressure of 10 mmHg or higher, or increase in heart rate of 30 bpm or higher within 3 minutes after passing from a supine to a standing position. Repeat test can be conducted at screening or Day -1 at the discretion of the principal investigator or delegate.
• History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week \[1 unit = 150 mL of wine, 375 mL of mid strength beer, or 30 mL of 40% alcohol\]).
• History of significant drug abuse within 1 year prior to screening or use of drugs such as marijuana within 3 months prior to the screening visit or drugs such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives within 1 year prior to screening.
• Participation in a clinical research study involving the administration of an investigational drug or device within 30 days prior to the first dosing.
• Administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing.
• Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
• prescription medications within 14 days prior to the first dosing;

Sponsors & Collaborators

• Chengdu SciMount Pharmatech Co., Ltd.: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, SA 5000, Australia

Location

Study Officials

• Sepehr Shakib

  CMAX Clinical Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 5, 2020
• Study Start: June 25, 2020
• Primary Completion: July 26, 2021
• Study Completion: August 6, 2021
• Last Updated: March 11, 2022

Record last verified: 2021-07

Locations

AU (1)