| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabete Mellitus | Drug: YG1699 Drug: Placebos | Phase 1 |
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration.
The study consists of 2 parts: Part 1, SAD dose-escalation; Part 2, MAD dose-escalation.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 64 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Single Ascending Dose and Multiple Ascending Dose |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Double Blinded |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699 |
| Actual Study Start Date : | May 1, 2019 |
| Actual Primary Completion Date : | November 13, 2019 |
| Actual Study Completion Date : | November 13, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: SAD Cohort 1
5 mg YG1699 or Placebo
|
Drug: YG1699
YG1699 at Multiple Doses
Drug: Placebos Placebos
|
|
Experimental: SAD Cohort 2
10 mg YG1699 or placebo
|
Drug: YG1699
YG1699 at Multiple Doses
Drug: Placebos Placebos
|
|
Experimental: SAD Cohort 3
25 mg YG1699 or placebo
|
Drug: YG1699
YG1699 at Multiple Doses
Drug: Placebos Placebos
|
|
Experimental: SAD Cohort 4
50 mg YG1699 or placebo
|
Drug: YG1699
YG1699 at Multiple Doses
Drug: Placebos Placebos
|
|
Experimental: SAD Cohort 5
100 mg YG1699 or placebo
|
Drug: YG1699
YG1699 at Multiple Doses
Drug: Placebos Placebos
|
|
Experimental: MAD Cohort 1
5 mg YG1699 or placebo
|
Drug: YG1699
YG1699 at Multiple Doses
Drug: Placebos Placebos
|
|
Experimental: MAD Cohort 2
20 mg YG1699 or placebo
|
Drug: YG1699
YG1699 at Multiple Doses
Drug: Placebos Placebos
|
|
Experimental: MAD Cohort 3
50 mg YG1699 or placebo
|
Drug: YG1699
YG1699 at Multiple Doses
Drug: Placebos Placebos
|
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Female subjects have a negative urine pregnancy test result at screening and Day -1, and meet one of the following criteria:
Surgically sterile for at least 3 months prior to screening by one of the following means:
Postmenopausal, defined as the following:
Exclusion Criteria:
| United States, New Jersey | |
| Frontage Labs | |
| Secaucus, New Jersey, United States, 07094 | |
| Study Director: | Yalin Li, MD | Youngene Therapeutics Inc., Ltd. |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 14, 2019 | ||||
| First Posted Date ICMJE | May 16, 2019 | ||||
| Last Update Posted Date | January 11, 2021 | ||||
| Actual Study Start Date ICMJE | May 1, 2019 | ||||
| Actual Primary Completion Date | November 13, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Adverse events will be evaluated [ Time Frame: 76 Days ] Safety and Tolerability of YG1699
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses of YG1699 | ||||
| Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of YG1699 | ||||
| Brief Summary | This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration. | ||||
| Detailed Description |
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of YG1699 following single and multiple ascending oral dose administration. The study consists of 2 parts: Part 1, SAD dose-escalation; Part 2, MAD dose-escalation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: Single Ascending Dose and Multiple Ascending Dose Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Double Blinded Primary Purpose: Treatment
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| Condition ICMJE | Diabete Mellitus | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
64 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | November 13, 2019 | ||||
| Actual Primary Completion Date | November 13, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03953092 | ||||
| Other Study ID Numbers ICMJE | YG1699 -01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Youngene Therapeutics Inc., Ltd. | ||||
| Study Sponsor ICMJE | Youngene Therapeutics Inc., Ltd. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Youngene Therapeutics Inc., Ltd. | ||||
| Verification Date | January 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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