MT1013 Clinical TRIAL In Healthy Subject

Sponsor

Shaanxi Micot Technology Limited Company (Industry)

Overall Status

Completed

CT.gov ID

NCT04783090

Collaborator

WCCT Global (Industry)

Enrollment

Location

Arms

8.6

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: MT1013	Phase 1

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

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Randomized, double-blind single-dose, sequential SADRandomized, double-blind single-dose, sequential SAD

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This study will be double-blinded. The subjects and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the subject's treatment assignment (MT1013 or placebo). Blinding will be maintained until at least the clinical phase of the study is completed。

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 28, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Mar 17, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects. [Three months]
Assessment of adverse events

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WCCT Global, Inc.	Cypress	California	United States	90630

Sponsors and Collaborators

Shaanxi Micot Technology Limited Company
WCCT Global

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaanxi Micot Technology Limited Company

ClinicalTrials.gov Identifier:

NCT04783090

Other Study ID Numbers:

MT1013-I-A01

First Posted:

Mar 5, 2021

Last Update Posted:

Jul 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 29, 2022