Healthy VolunteerPhase 1NCT04783090
MT1013 Clinical TRIAL In Healthy Subject
A Phase 1 study testing MT1013 in people with Healthy Volunteer, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, single ascending dose administration phase one clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of MT1013 injection in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- MT1013
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2021to 17 Mar 2022
- 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 55 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), ≥18 and ≤55 years of age, with BMI >18.0 and <30.0 kg/m2 and body weight ≥45.0 kg for males and 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, GI, renal, hepatic, and metabolic disease.
- Females of childbearing potential who are sexually active with a non-sterile male partner 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:
- Capable of consent.
Who cannot join
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, hepatitis C, or Treponema pallidum antibody found during medical screening.
- Positive urine drug screen or urine cotinine test or alcohol breath test at screening.
- Positive fecal occult blood test at screening.
- History of clinically significant drug allergies.
- Positive pregnancy test at screening.
- Clinically significant ECG abnormalities (QTcF ≥450 ms) or a family history of long QT syndrome.
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- Clinically significant vital sign abnormalities at screening.
- History of significant alcohol abuse within 1 year prior to screening.
- History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard 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 or marketed drug or device within 30 days or 5 half-lives (whichever is longer) prior to the first dosing.
- Use of prohibited medications for the timeframes specified.
- Donation of plasma within 7 days prior to dosing.
- Breast-feeding subject.
- The combination of diseases that may affect the assessment of drug absorption, distribution, metabolism, excretion and safety data, or that can reduce compliance.
- Subjects with previous clinically significant history of epileptic seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Administration Phase 1 Clinical Trial to Evalute the Satety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of MT1013 Injection in Healthy Subjects
This is a randomized, double-blind, placebo-controlled, single ascending dose administration phase one clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of MT1013 injection in healthy subjects.
Read the detailed description
This will be a single center, Phase 1, randomized, double-blind single-dose, sequential SAD study.
This SAD study will consist of up to 5 cohorts (1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving the active study drug and 2 subjects receiving matching placebo).
A staggered dosing schedule will be used for each dose level administered under fasting conditions. Two (2) sentinel subjects (1 active and 1 placebo) will be dosed first (a minimum of 1 hour apart) and the remaining 6 subjects will be dosed no sooner than the next day (each dosed at least 15 minutes apart).
Following completion of each dose level, a SRC will review the safety and tolerability data as well as the available PK data up to 48 hours in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose.
- Conditions
- Healthy Volunteer
- Being tested
- MT1013
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1013Drug
bispecific peptide as a CaSR agonist and a functional OGP analogue
| Study group | Role | What they receive |
|---|---|---|
| 1st cohort | Experimental | MT1013 injection at 2.5 mg. Receives: Drug: MT1013 |
| 2nd cohort | Experimental | MT1013 injection at 5 mg. Receives: Drug: MT1013 |
| 3rd cohort | Experimental | MT1013 injection at 10 mg. Receives: Drug: MT1013 |
| 4th cohort | Experimental | MT1013 injection at 15 mg. Receives: Drug: MT1013 |
| 5th cohort | Experimental | MT1013 injection at 20 mg. Receives: Drug: MT1013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects.
Assessment of adverse events
Measured: Three months
Secondary outcomes (8)
To characterize the pharmacokinetics (PK) of MT1013 for injection in healthy adult subjects
AUC0-t
Measured: 3 days
PK
AUC0-inf
Measured: 3 days
PK
Cmax
Measured: 3 days
PK
Tmax
Measured: 3 days
PK
T½ el
Measured: 3 days
To characterize the pharmacodynamics (PD) of MT1013 for injection in healthy adult subjects
Serum PTH value
Measured: 3 days
PD
Serum total calcium value
Measured: 3 days
PD
serum phosphorous value
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start28 Jun 2021
- Primary completion31 Dec 2021
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Model description
- Randomized, double-blind single-dose, sequential SAD
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783090
- Sponsor's protocol ID
- MT1013-I-A01
- Status last verified
- Mar 2022
- First submitted
- 20 Feb 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Administration Phase 1 Clinical Trial to Evalute the Satety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of MT1013 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04783090
- Acronym / sponsor ID
- MT1013-I-A01
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 5 Mar 2021 (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 is a randomized, double-blind, placebo-controlled, single ascending dose administration phase one clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of MT1013 injection in healthy subjects.
Detailed description
This will be a single center, Phase 1, randomized, double-blind single-dose, sequential SAD study.
This SAD study will consist of up to 5 cohorts (1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving the active study drug and 2 subjects receiving matching placebo).
A staggered dosing schedule will be used for each dose level administered under fasting conditions. Two (2) sentinel subjects (1 active and 1 placebo) will be dosed first (a minimum of 1 hour apart) and the remaining 6 subjects will be dosed no sooner than the next day (each dosed at least 15 minutes apart).
Following completion of each dose level, a SRC will review the safety and tolerability data as well as the available PK data up to 48 hours in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized, double-blind single-dose, sequential SAD
| Arm | Type | Receives |
|---|---|---|
| 1st cohort | Experimental | Drug: MT1013MT1013 injection at 2.5 mg. |
| 2nd cohort | Experimental | Drug: MT1013MT1013 injection at 5 mg. |
| 3rd cohort | Experimental | Drug: MT1013MT1013 injection at 10 mg. |
| 4th cohort | Experimental | Drug: MT1013MT1013 injection at 15 mg. |
| 5th cohort | Experimental | Drug: MT1013MT1013 injection at 20 mg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age, with BMI >18.0 and <30.0 kg/m2 and body weight ≥45.0 kg for males and females.
- Healthy as defined by:
- Females of childbearing potential who are sexually active with a non-sterile male partner 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:
- Capable of consent.
Key exclusion criteria (15 listed)
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, hepatitis C, or Treponema pallidum antibody found during medical screening.
- Positive urine drug screen or urine cotinine test or alcohol breath test at screening.
- Positive fecal occult blood test at screening.
- History of clinically significant drug allergies.
- Positive pregnancy test at screening.
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 |
|---|---|---|
| MT1013bispecific peptide as a CaSR agonist and a functional OGP analogue | Drug | 1st cohort, 2nd cohort, 3rd cohort, 4th cohort, 5th cohort |
Primary outcome
To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects.
Time frame: Three months
Assessment of adverse events
8 secondary outcomes
To characterize the pharmacokinetics (PK) of MT1013 for injection in healthy adult subjects
Time frame: 3 days
PK
Time frame: 3 days
PK
Time frame: 3 days
PK
Time frame: 3 days
PK
Time frame: 3 days
To characterize the pharmacodynamics (PD) of MT1013 for injection in healthy adult subjects
Time frame: 3 days
PD
Time frame: 3 days
PD
Time frame: 3 days
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 29 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 MT1013 in people with Healthy Volunteer, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in United States.
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 6 inclusion and 15 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 29 Jul 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 United States. 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?
To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects. (time frame: Three months). 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 29 Jul 2022.