Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC585 · 6 trials · 2 indications
change in %FVC, measured using Spirometer, from baseline to week 24
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone
Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585
Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib
To investigate the safety and tolerability of HEC585 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD and MAD
Geometric Mean of Maximum Observed Plasma Concentration of HEC585
area under the plasma concentration-time curve (AUC) from time zero to infinity
time of the maximum observed plasma concentration
apparent volume of distribution
apparent terminal elimination half-life
apparent oral clearance
| Arm | Type | Description |
|---|---|---|
| HEC585 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| pirfenidone | ACTIVE_COMPARATOR | - |
| HEC585 dose A | EXPERIMENTAL | Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks |
| HEC585 dose B | EXPERIMENTAL | Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks |
| HEC585 dose C | EXPERIMENTAL | Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks |
| HEC585 and Pirfenidone | EXPERIMENTAL | The DDI study of HEC585 and Pirfenidone |
| HEC585 and Nintedanib | EXPERIMENTAL | The DDI study of HEC585 and Nintedanib |
| A single dose HEC585（pilot trial arm） | EXPERIMENTAL | Healthy subjects receive a single dose of HEC585 |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 1） | EXPERIMENTAL | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 2） | EXPERIMENTAL | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 3） | EXPERIMENTAL | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single dose of HEC585 （Part 2，Fed/Fasting） | EXPERIMENTAL | Following an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| two-period study at 400 mg dose group (part 3，Fed) | EXPERIMENTAL | Healthy subjects receive Single/multiple doses of HEC585 or matching placebo in two cycles. |
| A single dose HEC585（A1） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A2） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585/FE（A3） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Treatment Period 1：No food prior to dosing；Treatment Period 2：High-fat meal prior to dosing |
| A single dose HEC585（A4） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A5） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A6） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A7） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A8） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B1） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B2） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B3） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B4） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B5） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B6） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Name | Type | Description |
|---|---|---|
| HEC585 | DRUG | HEC585 tablet, taken once daily |
| Placebo | DRUG | HEC585 Simulation Board, taken once daily |
| Pirfenidone | DRUG | Pirfenidone, taken three times a day |
| Nintedanib | DRUG | DDI of HEC585 andNintedanib：Nintedanib，twice a day，D1-D7 and D30-D36 |
Inclusion Criteria: 1. Voluntarily participate in this clinical study and sign the informed consent form before the study begins; 2. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted; 3. Be diagnosed with IPF...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE1 | NAL |