A SAD/MAD Study to Evaluate the Safety, Tolerability, PK of MT200605 in Healthy Subjects

NCT05948774 | Completed Phase 1 FDA Drug

• 1 other identifier: MT200605-I-C01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized, double-blind, placebo control, Phase I clinical trial is to evaluate the Safety, Tolerability, and Pharmacokinetics after Single Ascending Dose (SAD) and multiple Ascending Dose (MAD) of MT200605 for Injection in Healthy Subjects. The main questions it aims to answer are:

1. 1.The safety and tolerability of MT200605 injection in health subjects
2. 2.The Pharmacokinetic characteristic of MT200605 injction in health subjects

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (58)

• Adverse Events（AEs)

  For SAD, AEs will be recorded and evaluated for their seriousness, severity, and relationship to the study drug.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.

• Adverse Events（AEs)

  For MAD, AEs will be recorded and evaluated for their seriousness, severity, and relationship to the study drug.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.

• Vital signs (SAD)

  Vital signs measurements including blood pressure \[BP\] in mmHG.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.

• Vital signs (MAD)

  Vital signs measurements including blood pressure \[BP\] in mmHG.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks.

• Vital signs (SAD)

  Vital signs measurements including pulse rate \[PR\] in beats/minute.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Vital signs (MAD)

  Vital signs measurements including pulse rate \[PR\] in beats/minute.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Vital signs (SAD)

  Vital signs measurements including respiratory rate \[RR\] in breaths/minute.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Vital signs (MAD)

  Vital signs measurements including respiratory rate \[RR\] in breaths/minute.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Vital signs (SAD)

  Vital signs measurements including axillaty temperature \[AT\] in Celsius (°C).

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Vital signs (MAD)

  Vital signs measurements including axillaty temperature \[AT\] in Celsius (°C).

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (SAD)

  The ECG PR Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (SAD)

  The ECG QRS Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (SAD)

  The ECG RR Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (SAD)

  The ECG QT Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (SAD)

  The ECG QTc Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (MAD)

  The ECG PR Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (MAD)

  The ECG QRS Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (MAD)

  The ECG RR Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (MAD)

  The ECG QT Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• 12-lead electrocardiogram (ECG) recordings (MAD)

  The ECG QTc Interval will be used to evaluate and monitor the participants.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Head (SAD)

  A thorough physical examination will be performed at SAD stage, including head examination，the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Eyes (SAD)

  A thorough physical examination will be performed at SAD stage, including eyes examination，the descriptive name of scale （inspection） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Ears (SAD)

  A thorough physical examination will be performed at SAD stage, including ears examination，the descriptive name of scale （auscultation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Nose (SAD)

  A thorough physical examination will be performed at SAD stage, including nose examination，the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-throat (SAD)

  A thorough physical examination will be performed at SAD stage, including throat examination，the descriptive name of scale （inspection） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-neck (SAD)

  A thorough physical examination will be performed at SAD stage, including neck examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-lung (SAD)

  A thorough physical examination will be performed at SAD stage, including lung examination, the descriptive name of scale （palpation，percussion，auscultation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Abdomen (SAD)

  A thorough physical examination will be performed at SAD stage, including Abdomen examination，the descriptive name of scale （palpation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-skin (SAD)

  A thorough physical examination will be performed at SAD stage, including skin examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Musculoskeletal (SAD)

  A thorough physical examination will be performed at SAD stage, including musculoskeletal examination，the descriptive name of scale（inspection，palpation，percussion） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Cardiovascular (SAD)

  A thorough physical examination will be performed at SAD stage, including Cardiovascular examination，the descriptive name of scale（inspection, palpation, percussion, and asking for Anamnesis）will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-neurological (SAD)

  A thorough physical examination will be performed at SAD stage, including neurological examination，the descriptive name of scale（palpation, percussion）will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-lung (MAD)

  A simple physical examination will be performed at MAD stage, including lung examination, the descriptive name of scale （palpation，percussion，auscultation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Abdomen (MAD)

  A simple physical examination will be performed at MAD stage, including Abdomen examination，the descriptive name of scale （palpation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-skin (MAD)

  A simple physical examination will be performed at MAD stage, including skin examination, the descriptive name of scale （inspection，palpation） will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Physical examinations-Cardiovascular (MAD)

  A simple physical examination will be performed at MAD stage, including Cardiovascular examination，the descriptive name of scale（inspection, palpation, percussion, and asking for Anamnesis）will be used to report this outcome measure.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-hematology (SAD)

  The hematology testing will be performed, the MCH will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-hematology (SAD)

  The hematology testing will be performed,the Hematocrit will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-hematology (SAD)

  The hematology testing will be performed,the Hemoglobin will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-biochemistry (SAD)

  The biochemistry testing will be performed, the eGFR will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-biochemistry (SAD)

  The biochemistry testing will be performed, the serum creatinine will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Urinalysis (SAD)

  The Urinalysis will be performed, the urine albumin-to-creatinine ratio (UACR) will be calculated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Coagulation (SAD)

  The Urinalysis will be performed, the PT will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Coagulation (SAD)

  The Urinalysis will be performed, the aPTT will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Coagulation (SAD)

  The Urinalysis will be performed, the INR will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Cardiac Enzymes (SAD)

  The Urinalysis will be performed, the TnT will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Cardiac Enzymes (SAD)

  The Urinalysis will be performed, the TnI will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-hematology (MAD)

  The hematology testing will be performed, the MCH will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-hematology (MAD)

  The hematology testing will be performed, the Hematocrit will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-hematology (MAD)

  The hematology testing will be performed, the Hemoglobin will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-biochemistry (MAD)

  The biochemistry testing will be performed, the eGFR will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-biochemistry (MAD)

  The biochemistry testing will be performed, the serum creatinine will be evaluated

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Urinalysis (MAD)

  The Urinalysis will be performed, the urine albumin-to-creatinine ratio (UACR) will be calculated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Coagulation (MAD)

  The Urinalysis will be performed, the PT will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Coagulation (MAD)

  The Urinalysis will be performed, the aPTT will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Coagulation (MAD)

  The Urinalysis will be performed, the INR will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Cardiac Enzymes (MAD)

  The Urinalysis will be performed, the TnT will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

• Clinical laboratory test-Cardiac Enzymes (MAD)

  The Urinalysis will be performed, the TnI will be evaluated.

  From the date of screening until the date of last follow-up visit or early termination and end of study, assessed up to 4 weeks

Secondary Outcomes (30)

• Plasma PK of free MT200605 and total MT200605 (SAD)

  Up to 2 Days.

• Plasma PK of free MT200605 and total MT200605 (SAD)

  Up to 2 Days.

• Plasma PK of free MT200605 and total MT200605 (SAD)

  Up to 2 Days.

• Plasma PK of free MT200605 and total MT200605 (SAD)

  Up to 2 Days.

• Plasma PK of free MT200605 and total MT200605 (SAD)

  Up to 2 Days.

Study Arms (2)

MT200605 for injection

EXPERIMENTAL

The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. The MT200605 in SAD and MAD following Intravenous Infusion Administration by using infusion pump in Healthy Subjects.

Drug: MT200605 for Injection

MT200605 Placebo

PLACEBO COMPARATOR

The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. The MT200605 Placebo in SAD and MAD following Intravenous Infusion Administration by using infusion pump in Healthy Subjects.

Drug: MT200605 Placebo

Interventions

MT200605 for Injection DRUG

Two stages (SAD, MAD) were designed in this study. For SAD, the MT200605 will single Intravenous (IV) infusion for 1h with the dose level as 0.15 mg/kg、0.3 mg/kg、0.6 mg/kg、0.9 mg/kg、1.2 mg/kg. For MAD, the participants will IV infusion of the MT200605 for 7 days with 2 times per day under the dose level of 0.3 mg/kg、0.6 mg/kg、1.2 mg/kg. The dosing frequency will be Q12h. The drug/placebo in day 7 will be only administrated for 1 time on morning. The infusion duration will be 1h.

Also known as: MT200605

MT200605 for injection

MT200605 Placebo DRUG

Two stages (SAD, MAD) were designed in this study. For SAD, the MT200605 Placebo will single Intravenous (IV) infusion for 1h with the dose level as 0.15 mg/kg、0.3 mg/kg、0.6 mg/kg、0.9 mg/kg、1.2 mg/kg. For MAD, the participants will IV infusion of the MT200605 Placebo for 7 days with 2 times per day under the dose level of 0.3 mg/kg、0.6 mg/kg、1.2 mg/kg. The dosing frequency will be Q12h. The drug/placebo in day 7 will be only administrated for 1 time on morning. The infusion duration will be 1h.

MT200605 Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, ≥ 18 and ≤ 50 years of age with BMI ≥ 18.0 and ≤ 28.0 kg/m\^2
• Healthy as defined by:
• The absence of clinically significant illness and major surgery within 4 weeks prior to study drug administration.
• The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• Participants have no fertility plan, no sperm or egg donation plan in the next 6 months and voluntarily use effective contraception; Female subjects with negative serum pregnancy test results.
• Can understand the study process of the clinical trial, and provide the signed ICF of joinning the clinical trial.

You may not qualify if:

• Participants will be excluded from the study if any of the following applies:
• Any clinically significant abnormal finding at physical examination.
• Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody at screening, or active infections.
• Positive pregnancy test or lactating female subject.
• Positive results of urine drug screen and breath alcohol test.
• History of significant allergic reactions (e.g., Immediate hypersensitivity, hypersensitivity, angioedema) to any drug that the Investigator judges to be clinically significant.
• Clinically significant ECG abnormalities (QTcF ≥ 450 ms) or vital signs abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90 mmHg, HR less than 50 or over 100 bpm) at screening.
• History of drug abuse within 1 year prior to screening or using of the recreational drugs (such as marijuana, cocaine, phencyclidine \[PCP\], opioid derivatives (including Morphine, buprenorphine, methadone) or amphetamine derivatives within 3 months prior to screening.
• History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 355 mL of 5% beer, or 150 mL of 12% wine, or 45 mL of 40% distilled alcohol).
• Donation or loss of more than 500 mL blood within 2 months prior to study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months prior to screening, or plans to donate blood during the study or within 3 months after the study.
• Estimated glomerular filtration rate (eGFR) \<60 mL/min at screening (estimated with the MDRD equation).
• Participants daily smoking of cigarettes amounts \> 5 prior to the 3 months of screening, or get used to usage of nicotine-containing products, or participants who is not accept forbidden of any cigarettes products.
• Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
• Depot injection or implant within 3 months prior to the first dosing.
• Any drug or substances known to be strong inhibitors or strong inducers of CYP3A4/5, transporters of P-gp (e.g. rifampin, St, John´s Wort) within 30 days prior to the first dosing

Sponsors & Collaborators

• Shaanxi Micot Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 101100, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• RuiHua Dong, PhD

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be double-blinded for MT200605/matching placebo. 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 (MT200605 or placebo).Blinding will be maintained until at least the clinical phase of the study is completed. Since the outward appearance of MT200605 and Placebo is not totally same after preparations, the unblinded study nurses and Pharmacists were set up to avoid the effects of blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 17, 2023
• Study Start: July 11, 2023
• Primary Completion: January 22, 2024
• Study Completion: February 11, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)