MT1013 Clinical TRIAL In Healthy Subject

NCT04783090 | Completed Phase 1 FDA Drug

• 1 other identifier: MT1013-I-A01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects.

  Assessment of adverse events

  Three months

Secondary Outcomes (8)

• To characterize the pharmacokinetics (PK) of MT1013 for injection in healthy adult subjects

  3 days

• PK

  3 days

• PK

  3 days

• PK

  3 days

• PK

  3 days

Study Arms (5)

1st cohort

EXPERIMENTAL

MT1013 injection at 2.5 mg.

Drug: MT1013

2nd cohort

EXPERIMENTAL

MT1013 injection at 5 mg.

Drug: MT1013

3rd cohort

EXPERIMENTAL

MT1013 injection at 10 mg.

Drug: MT1013

4th cohort

EXPERIMENTAL

MT1013 injection at 15 mg.

Drug: MT1013

5th cohort

EXPERIMENTAL

MT1013 injection at 20 mg.

Drug: MT1013

Interventions

MT1013 DRUG

bispecific peptide as a CaSR agonist and a functional OGP analogue

1st cohort; 2nd cohort; 3rd cohort; 4th cohort; 5th cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaanxi Micot Pharmaceutical Technology Co., Ltd.: lead
• WCCT Global: collaborator

Study Sites (1)

WCCT Global, Inc.

Cypress, California, 90630, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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。
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind single-dose, sequential SAD

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 5, 2021
• Study Start: June 28, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 17, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)