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SGC001

Phase 1

Anterior Myocardial Infarction | Small molecule | Cardiovascular |Co-Diagnostics, Inc.|Last Updated: Jan 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07091929A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myocardial InfarctionPHASE1 COMPLETED 38 — — Jan 20, 2025Jul 18, 2025Jan 12, 20264 China
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Study Endpoints
Primary Endpoints
Adverse events (AE), Serious adverse events (SAE)
From randomisation to end-of-study (up to 30 days)
Recommended Phase 2 dose (RP2D)
From randomisation to end-of-study (up to 30 days)

Determination of the Recommended Phase II Dose

Secondary Endpoints
Peak Concentration (Cmax)
From randomisation to end-of-study (up to 30 days)
Time to Maximum Concentration (Tmax)
From randomisation to end-of-study (up to 30 days)
Area under the plasma concentration-time curve from time zero to the last quantifiable rime point after administration (AUC0-t)
From randomisation to end-of-study (up to 30 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SGC001EXPERIMENTALEnrolled anterior STEMI patients will receive standard clinical treatment and a single dose of SGC001 on Day 1 (D1) according to their randomized dosing group. The study drug should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection will be administered over 10 minutes.
PlaceboPLACEBO_COMPARATOREnrolled anterior STEMI patients will receive standard clinical treatment and a single dose of placebo on Day 1 (D1) according to their randomized dosing group. The study drug should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection will be administered over 10 minutes.
Interventions
NameTypeDescription
SGC001DRUGThe single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes.
PlaceboDRUGThe single dose should be administered within 6 hours after the onset of acute myocardial infarction symptoms, with earlier administration preferred. The intravenous injection should be administered over 10 minutes.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Male or female subjects aged 18\~75 years (both inclusive) 2. Anterior STEMI, defined as: (a) Persistent chest pain or discomfort \> 30 minutes; AND (b) Persistent ST-segment elevation ≥0.1 mV in ≥2 contiguous precordial leads (V1-V6) on the admission ECG, with ≥0.2 mV requir...

Countries:China
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