Healthy VolunteersPhase 1NCT04296799
A Phase 1 Study of SMP-100 in Normal Healthy Volunteers
A Phase 1 study testing SMP-100 in people with Healthy Volunteers, run by Chengdu SciMount Pharmatech Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SMP-100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Jun 2020to 6 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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;
- simultaneous use of a male condom and, for the female partner, a diaphragm.
- Male subjects (including men who have had a vasectomy) with a pregnant or same-sex partner must agree to use a condom from the first study drug administration until at least 90 days after the last study drug administration.
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
- Willing to take off dentures or mouth piercing at the time of dosing.
- Capable of consent.
Who cannot join
- 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.
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- 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;
- over-the-counter products and natural health products (including herbal remedies homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days prior to the first dosing, with the exception of the occasional use of paracetamol (up to 2 g daily);
- any prescription or over-the-counter medication or natural health products used for the treatment of irregular bowel transit (e.g. diarrhea, constipation) within 4 weeks prior to the first dosing;
- depot injection or implant of any drug within 3 months prior to the first dosing;
- use of any drugs known to induce or inhibit hepatic metabolism (including St. John's Wort [hypericin]) within 14 days prior to the first dosing.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- Presence of:
- orthodontic braces or orthodontic retention wires, or
- any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.
- Breast-feeding subject.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of SMP-100 in Normal Healthy Volunteers
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.
Read the detailed description
SMP-100 is a novel serotonin receptor 3 (5-HT3) partial agonist which has been designed to be a safe and effective therapy for irritable bowel syndrome (IBS) patients .
This will be a single center, Phase 1, double-blind, placebo-controlled, randomized, sequential single ascending dose (SAD)/ multiple ascending dose (MAD) study to assess the safety, tolerability, and PK of SMP-100 in healthy adult male and female subjects. The study will be divided into two parts:
Part A: SAD cohorts Part A 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. Each subject will participate in only one cohort. Efforts will be made to randomize at least 3 subjects of each gender in each cohort.
Part B: MAD cohorts Part B 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). Each study subject will participate in only one cohort. Efforts will be made to randomize at least 3 subjects of each gender in each cohort.
For both Part A and Part B, subjects who withdraw or are withdrawn from the study after dosing, for reasons other than safety and tolerability, may be replaced after consultation between the Safety Review Committee (SRC) members. The total number of subjects dosed (including potential replacement subjects) will remain within a maximum of 10 subjects per cohort.
- Conditions
- Healthy Volunteers
- Being tested
- SMP-100, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMP-100Drug
Also called SMP-100 oral solution, ALB-137391(a), CSTI-300
SAD/MAD
PlaceboDrug
Also called Placebo oral solution
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: SMP-100; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 13±2 days post last dose
Secondary outcomes (23)
PK Endpoints AUC0-t of SAD
area under the concentration-time curve from time zero to the last non-zero concentration (AUC0-t)
Measured: 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
area under the concentration-time curve from time zero to time 24 hours (AUC0-24)
Measured: 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
area under the concentration-time curve from time zero to infinity (extrapolated) (AUC0 inf)
Measured: 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
maximum plasma concentration (Cmax)
Measured: 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
time of maximum concentration ( Tmax)
Measured: 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 T½ el of SAD
elimination half-life ( T½ el)
Measured: 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 Cl/F of SAD
Total body clearance, calculated as Dose / AUC0-inf (Cl/F)
Measured: 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 Vz/F of SAD
apparent volume of distribution, calculated as Dose / (Kel * AUC0-inf) (Vz/F)
Measured: 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 MAD
area under the concentration-time curve from time zero to time 24 hours (AUC0-24)
Measured: Day 1
PK Endpoints Cmax of MAD
maximum plasma concentration (Cmax)
Measured: Day 1
PK Endpoints Tmax of MAD
time of maximum concentration ( Tmax)
Measured: Day 1
PK Endpoints T½ el of MAD
elimination half-life ( T½ el)
Measured: Day 1
PK Endpoints AUC0-τ of MAD
area under the concentration-time curve at steady-state from time zero to time 24 hours ( AUC0-τ)
Measured: Day 14
PK Endpoints AUC0-48 of MAD
area under the concentration-time curve from time zero to time 48 hours ( AUC0-48)
Measured: Day 14
PK Endpoints AUC0-72 of MAD
area under the concentration-time curve from time zero to time 72 hours ( AUC0-72)
Measured: Day 14
PK Endpoints Cmax ss of MAD
maximum observed concentration at steady-state （Cmax ss）
Measured: Day 14
PK Endpoints Tmax ss of MAD
time of maximum concentration at steady-state（Tmax ss）
Measured: Day 14
PK Endpoints Cmin ss of MAD
minimum observed concentration at steady-state（Cmin ss）
Measured: Day 14
PK Endpoints AUC0- t of MAD
area under the concentration-time curve from time zero to the last non-zero concentration（AUC0- t）
Measured: Day 14
PK Endpoints T½ el of MAD
elimination half-life（T½ el）
Measured: Day 14
PK Endpoints Clss/F of MAD
total body clearance at steady-state, calculated as Dose / AUC0-inf（Clss/F）
Measured: Day 14
PK Endpoints Vz ss/F of MAD
apparent volume of distribution at steady-state, calculated as Dose / (Kel * AUC0-inf)（Vz ss/F）
Measured: Day 14
Plasma concentration observed of MAD
Plasma concentration observed will be presented
Measured: before treatment administrations (Ctrough) during repeated dosing (Days 2-13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start25 Jun 2020
- Primary completion26 Jul 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, Principal investigator, CMAX Clinical Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296799
- Sponsor's protocol ID
- ChengduSciMount
- Status last verified
- Jul 2021
- First submitted
- 26 Feb 2020
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of SMP-100 in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04296799
- Acronym / sponsor ID
- ChengduSciMount
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Chengdu SciMount Pharmatech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
SMP-100 is a novel serotonin receptor 3 (5-HT3) partial agonist which has been designed to be a safe and effective therapy for irritable bowel syndrome (IBS) patients .
This will be a single center, Phase 1, double-blind, placebo-controlled, randomized, sequential single ascending dose (SAD)/ multiple ascending dose (MAD) study to assess the safety, tolerability, and PK of SMP-100 in healthy adult male and female subjects. The study will be divided into two parts:
Part A: SAD cohorts Part A 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. Each subject will participate in only one cohort. Efforts will be made to randomize at least 3 subjects of each gender in each cohort.
Part B: MAD cohorts Part B 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). Each study subject will participate in only one cohort. Efforts will be made to randomize at least 3 subjects of each gender in each cohort.
For both Part A and Part B, subjects who withdraw or are withdrawn from the study after dosing, for reasons other than safety and tolerability, may be replaced after consultation between the Safety Review Committee (SRC) members. The total number of subjects dosed (including potential replacement subjects) will remain within a maximum of 10 subjects per cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: SMP-100, Drug: PlaceboThe 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. |
| Multiple Ascending Dose | Experimental | Drug: SMP-100, Drug: PlaceboThe 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). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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:
- 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:
- 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).
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMP-100Also: SMP-100 oral solution, ALB-137391(a), CSTI-300SAD/MAD | Drug | Multiple Ascending Dose, Single Ascending Dose |
| PlaceboAlso: Placebo oral solutionPlacebo | Drug | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
Safety Endpoints of SAD
Time frame: 10±2 days post dose
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.
Safety Endpoints of MAD
Time frame: 13±2 days post last dose
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.
23 secondary outcomes
PK Endpoints AUC0-t of SAD
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 T½ el of SAD
Time frame: 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 Cl/F of SAD
Time frame: 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 Vz/F of SAD
Time frame: 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 MAD
Time frame: Day 1
PK Endpoints Cmax of MAD
Time frame: Day 1
PK Endpoints Tmax of MAD
Time frame: Day 1
PK Endpoints T½ el of MAD
Time frame: Day 1
PK Endpoints AUC0-τ of MAD
Time frame: Day 14
PK Endpoints AUC0-48 of MAD
Time frame: Day 14
PK Endpoints AUC0-72 of MAD
Time frame: Day 14
PK Endpoints Cmax ss of MAD
Time frame: Day 14
PK Endpoints Tmax ss of MAD
Time frame: Day 14
PK Endpoints Cmin ss of MAD
Time frame: Day 14
PK Endpoints AUC0- t of MAD
Time frame: Day 14
PK Endpoints T½ el of MAD
Time frame: Day 14
PK Endpoints Clss/F of MAD
Time frame: Day 14
PK Endpoints Vz ss/F of MAD
Time frame: Day 14
Plasma concentration observed of MAD
Time frame: before treatment administrations (Ctrough) during repeated dosing (Days 2-13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sepehr Shakib principal investigator
CMAX Clinical Research Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SMP-100 in people with Healthy Volunteers, run by Chengdu SciMount Pharmatech Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoints of SAD (time frame: 10±2 days post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.