MT1013 Clinical TRIAL In Healthy Subject

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: MT1013

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.

2. Healthy as defined by:

   1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
   2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, GI, renal, hepatic, and metabolic disease.
3. 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:
4. Capable of consent.

Exclusion Criteria:

1. 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.
2. Positive urine drug screen or urine cotinine test or alcohol breath test at screening.
3. Positive fecal occult blood test at screening.
4. History of clinically significant drug allergies.
5. Positive pregnancy test at screening.
6. Clinically significant ECG abnormalities (QTcF ≥450 ms) or a family history of long QT syndrome.
7. Clinically significant vital sign abnormalities at screening.
8. History of significant alcohol abuse within 1 year prior to screening.
9. 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.
10. 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.
11. Use of prohibited medications for the timeframes specified.
12. Donation of plasma within 7 days prior to dosing.
13. Breast-feeding subject.
14. The combination of diseases that may affect the assessment of drug absorption, distribution, metabolism, excretion and safety data, or that can reduce compliance.
15. Subjects with previous clinically significant history of epileptic seizures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shaanxi Micot Technology Limited Company
• Collaborators: WCCT Global

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): March 17, 2022

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MT1013-I-A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No