MT1013 Clinical TRIAL In Healthy Subject

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: MT1013


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized, double-blind single-dose, sequential SAD
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st cohort<br>MT1013 injection at 2.5 mg. | Drug: MT1013<br>* bispecific peptide as a CaSR agonist and a functional OGP analogue<br>|
| Experimental: 2nd cohort<br>MT1013 injection at 5 mg. | Drug: MT1013<br>* bispecific peptide as a CaSR agonist and a functional OGP analogue<br>|
| Experimental: 3rd cohort<br>MT1013 injection at 10 mg. | Drug: MT1013<br>* bispecific peptide as a CaSR agonist and a functional OGP analogue<br>|
| Experimental: 4th cohort<br>MT1013 injection at 15 mg. | Drug: MT1013<br>* bispecific peptide as a CaSR agonist and a functional OGP analogue<br>|
| Experimental: 5th cohort<br>MT1013 injection at 20 mg. | Drug: MT1013<br>* bispecific peptide as a CaSR agonist and a functional OGP analogue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects. | Assessment of adverse events | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics (PK) of MT1013 for injection in healthy adult subjects | AUC0-t | 3 days | 
| PK | AUC0-inf | 3 days | 
| PK | Cmax | 3 days | 
| PK | Tmax | 3 days | 
| PK | T½ el | 3 days | 
| To characterize the pharmacodynamics (PD) of MT1013 for injection in healthy adult subjects | Serum PTH value | 3 days | 
| PD | Serum total calcium value | 3 days | 
| PD | serum phosphorous value | 3 days |