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| Name | Class |
|---|---|
| WCCT Global | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st cohort | Experimental | MT1013 injection at 2.5 mg. |
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| 2nd cohort | Experimental | MT1013 injection at 5 mg. |
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| 3rd cohort | Experimental | MT1013 injection at 10 mg. |
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| 4th cohort | Experimental | MT1013 injection at 15 mg. |
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| 5th cohort | Experimental | MT1013 injection at 20 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1013 | Drug | bispecific peptide as a CaSR agonist and a functional OGP analogue |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of MT1013 for injection in healthy adult subjects. | Assessment of adverse events | Three months |
| 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 |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global, Inc. | Cypress | California | 90630 | United States |
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Randomized, double-blind single-dose, sequential SAD
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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。
| 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 |