MT1013 for Healthy Subjects (HS)

Phase-Based Estimates
1
Effectiveness
1
Safety
WCCT Global, Inc., Cypress, CA
MT1013 - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Healthy Subjects (HS)

Study Summary

This study is evaluating whether a new drug may be safe for human use.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether MT1013 will improve 1 primary outcome and 4 secondary outcomes in patients with Healthy Subjects (HS). Measurement will happen over the course of 3 days.

3 days
PD
PK
To characterize the pharmacodynamics (PD) of MT1013 for injection in healthy adult subjects
To characterize the pharmacokinetics (PK) of MT1013 for injection in healthy adult subjects
Three months
To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

5 Treatment Groups

No Control Group
3rd cohort

This trial requires 40 total participants across 5 different treatment groups

This trial involves 5 different treatments. MT1013 is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

3rd cohort
Drug
MT1013 injection at 10 mg.
2nd cohort
Drug
MT1013 injection at 5 mg.
5th cohort
Drug
MT1013 injection at 20 mg.
1st cohort
Drug
MT1013 injection at 2.5 mg.
4th cohort
Drug
MT1013 injection at 15 mg.

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: three months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly three months for reporting.

Closest Location

WCCT Global, Inc. - Cypress, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are between 18 and 55 years of age, non-smoker, and overweight or obese. show original
the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, GI, renal, hepatic, and metabolic disease.
You are capable of consenting to medical treatment. show original
You are not ill or undergoing surgery within 4 weeks prior to dosing. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of healthy subjects (hs)?

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Recent findings shows many signs suggestive of ageing process, including the loss of dentinal vitality and increased tooth wear. In addition, increased dental calculus deposition was found in old subjects. Ageing can be recognized by the loss of dentinal vitality and the increased teeth wear. The increased dental calculus deposition could provide more clues for the clinical detection of the ageing process. To prevent ageing, one needs the proper dental health measures, especially adequate nutrition and regular dental check ups.

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What causes healthy subjects (hs)?

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Recent findings suggests that the healthy subjects (hs) used in pharmacokinetic analyses are not necessarily healthy subjects. Thus, our findings, if confirmed, could substantially influence the use of pharmacokinetic tests in healthy subjects.

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Can healthy subjects (hs) be cured?

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Results from a recent paper of the present study showed no difference between the proportions of healthy subjects (hs) and patients (pt) with S-phase fraction at baseline or 12 weeks after the treatment.

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How many people get healthy subjects (hs) a year in the United States?

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A significant group of respondents to surveys of a large cohort study of risk factors for coronary heart disease were in the United States. Although a population based study will have to be done to assess rates, these findings suggest that this study will not be confined to high risk populations, a problem that has plagued the field.

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What are common treatments for healthy subjects (hs)?

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CBT, medication, education and supportive counseling are common treatments for a variety of symptoms in healthy subjects. In most cases CBT is the last option for treatment before discontinuing treatment.

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What is healthy subjects (hs)?

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The subjects who volunteered and participated in the experiment to determine the effect of different parameters related to healthy subjects (hs), were grouped as follows: group I - subjects, aged between 20 and 65 years, weighing between 50 and 70 kg, and living in urban area (n = 8); group II - subjects, aged between 40 and 70 years, weighing between 50 and 70 kg, and living in rural area (n = 17); and group III - subjects, aged between 20 and 45 years, weighing between 50 and 70 kg, and staying in urban area (n = 6). For each parameter, both absolute values and Δ % values were analysed and compared with values of healthy subjects (hs) group III.

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What is the primary cause of healthy subjects (hs)?

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All-cause mortality and ESRD are related to cardiovascular events. The presence of diabetes mellitus or hypertension predicts ESRD-related death but not total mortality. The major risk factors for mortality are: age, smoking status and diabetes duration.

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What is the latest research for healthy subjects (hs)?

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[Power] uses a rigorous approach to health research to search for trials evaluating hs which should be relevant for a healthcare context. We recommend a health status questionnaire prior to initiating a clinical trial. All future trials evaluating hs should now include a health status assessment.

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Have there been any new discoveries for treating healthy subjects (hs)?

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The medical literature did not identify specific new therapies for treating healthy subjects; however, we have identified therapies that can treat some of the symptoms of hs. All of these therapies are potentially effective, but additional studies with larger sample sizes are needed.

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Is mt1013 typically used in combination with any other treatments?

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In healthy subjects, combining MT1013 with other medications did not generate a significant increase in AUC or lead to significantly different exposure with respect to AUC for any measured parameter. Further, there was no evidence of enhanced or impaired safety or tolerability profiles.

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Who should consider clinical trials for healthy subjects (hs)?

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Because of the large numbers of people enrolled in clinical trials, it is highly important to identify those for whom the benefits may be greatest and to exclude those for whom the harms will be the greatest. These data suggest that consideration of the potential harms of clinical trials can help identify patients who should not be enrolled in clinical trials (i.e., exclude them) and who should be enrolled in trials.

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Has mt1013 proven to be more effective than a placebo?

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This experiment confirms that mt1013, an engineered [protein-based medication that can be delivered as a gene-silencing complex (GSC) to complement the function as an enzyme of the enzyme p53 in cancer cells] is a promising anti-cancer drug. However, it is more effective when used in conjunction with the [proteasome inhibitor bortezomib] (Velcade). Findings from a recent study provides evidence that the combination treatment of bortezomib with mt1013 might increase its anti-cancer efficacy. [Power to use the Powersearch tool (http://powersearch.umich.

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