HealthyPhase 1NCT05997641
Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects
A Phase 1 study testing DF-003 in people with Healthy and Safety and Tolerability, run by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm) at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics (PK; drug metabolism) of DF-003 after oral administration of single and multiple ascending doses in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Safety and Tolerability
- What is being tested?
- DF-003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form (ICF).
- Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study, and likeliness to complete the study as planned, per the Investigator's opinion.
- Healthy adult male or female.
- If male, meets one of the following criteria:
- Is able to procreate and agrees not to donate sperm from the first study drug administration to at least 90 days after the last study drug administration in addition to:
- Having a female partner who is postmenopausal, surgically sterile, or otherwise incapable of becoming pregnant, OR
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- Having a female partner who is a woman of childbearing potential and agrees to use a highly effective method of contraception from the first study drug administration to at least 90 days after the last study drug administration, OR
- Is unable to procreate; defined as surgically sterile (ie, has undergone a vasectomy at least 180 days prior to the first study drug administration).
- If female, meets one of the following criteria:
- Physiological postmenopausal status, defined as the following:
- Amenorrhea for at least 12 months prior to the first study drug administration (without an alternative medical condition); AND
- Follicle stimulating hormone (FSH) levels ≥40 mIU/mL at Screening;
- In the absence of 12 months of amenorrhea, 2 FSH measurements at least 3 months apart and in the postmenopausal range must be documented.
- Surgical postmenopausal status, defined as having had a bilateral oophorectomy or bilateral salpingo-oophorectomy with FSH levels ≥ 40 mIU/mL at Screening.
- Aged at least 18 years but not older than 55 years at the time of Screening.
- Body mass index (BMI) within 18.0 kg/m^2 to 32.0 kg/m^2, inclusively.
- Non- or ex-smoker (An ex-smoker is defined as someone who completed stopped using nicotine products for at least 3 months prior to the first study drug administration).
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination, vital signs, eye examination, and/or ECG, as determined by an Investigator.
- A 12-lead ECG that meets the following criteria (ECG intervals will be based on the mean value of triplicate ECGs [rounded to the nearest whole number] collected at Screening):
- Heart rate ≥45 to ≤100 beats per minute
- QT interval corrected for heart rate (QTc) according to Fridericia's formula (QTcF) ≤450 ms (males) or ≤470 ms (females)
- QRS interval <120 ms
- PR interval ≤200 ms
Who cannot join
- Female who is lactating.
- Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
- Female using the following systemic contraceptives: oral, patch or vaginal ring, in the 28 days prior to the first study drug administration.
- Female using hormone replacement therapy in the 28 days prior to the first study drug administration.
- Female using the following systemic contraceptives: injections or implant, or hormone-releasing intrauterine device in the 13 weeks prior to the first study drug administration.
- History of significant hypersensitivity to products related to DF-003 (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
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- Presence or history of significant gastrointestinal, liver or kidney disease, or surgery (with the exception of cholecystectomy and appendectomy) that may affect drug bioavailability.
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, rheumatologic, neoplastic, metabolic, or dermatologic disease.
- Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgment.
- Use of contact lenses or eyeglasses.
- Presence of clinically significant visual acuity or slit-lamp biomicroscopy abnormalities at the Screening visit, as defined by medical judgement.
- History or family history of chronic inflammatory skin disease (eg, psoriasis, atopic dermatitis, drug-related rash, or chronic urticaria), or immune or autoimmune related disorders, diseases, or syndromes.
- Major surgery (eg, requiring general anesthesia) within 12 weeks before Screening, during the study, or within 12 weeks after the last dose of study drug. NOTE: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.
- Presence of renal dysfunction at Screening (eg, estimated glomerular filtration rate < 90 mL/min/1.73 m^2 calculated by the Chronic Kidney Disease Epidemiology Collaboration formula).
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).
- Any clinically significant illness including current acute or chronic infections in the 28 days prior to the first study drug administration.
- Use of any prescription drugs in the 28 days prior to the first study drug administration, that in the opinion of an Investigator would put into question the status of the participant as healthy.
- Use of St. John's wort in the 28 days prior to the first study drug administration.
- Use of any over-the-counter medications 7 days prior to the first study drug administration. Subjects will be reminded that over-the-counter medications include cold preparations, aspirin, vitamins and natural products used for therapeutic benefits, and antacid preparations.
- Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first drug administration.
- Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen, or hepatitis C virus tests.
- Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
- Intake of an IP in the 4 weeks (or 5 half-lives, whichever is longer) prior to the first study drug administration.
- Intake of any biological products in the 12 months prior to the first study drug administration.
- Current participation in another clinical or medical interventional research study.
- Employee of the Sponsor, Investigator or study site with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or Investigator.
- Donation of plasma in the 7 days prior to the first study drug administration.
- Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to the first study drug administration.
- Presence or history of eye lens opacification (cataracts) and eye lens degeneration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Los Angeles, Inc
Cypress, California, 90630
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered DF-003 Following Single (Part 1) and Multiple (Part 2) Ascending Doses in Healthy Subjects
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics (PK; drug metabolism) of DF-003 after oral administration of single and multiple ascending doses in healthy subjects. The choice of using healthy subjects is standard in establishing the preliminary safety and PK profile of a drug.
DF-003 is a potent small molecule inhibitor of alpha-kinase 1 (ALPK1), which plays an important role in immunity and inflammation. DF-003 can inhibit the immune inflammatory response and has been shown to reduce renal fibrosis in preclinical models. Thus, this study aims to determine the role of DF-003 in the treatment of chronic kidney disease.
Read more
This study will include 2 parts. Part 1 is a single ascending dose (SAD) phase with an optional food effect (FE) assessment, while Part 2 is a multiple ascending dose (MAD) phase. Part 1 - SAD Phase with optional FE assessment will include approximately 64 subjects (up to 8 cohorts of 8 subjects each) and Part 2 - MAD Phase will include approximately 32 subjects (up to 4 cohorts of 8 subjects each). Therefore, up to 96 subjects will be included in the study.
Study participants will be screened approximately 42 days within the first scheduled administration of study medication. Screening data will be reviewed to determine subject eligibility. In Part 1, subjects will be randomly assigned to receive a single oral dose of DF-003 (3 x 1 milligram capsules) or matching placebo. The doses to be evaluated in Part 2 will be determined based on review of the available safety and PK data from Part 1.
Subjects will be monitored for adverse events (AEs) and data will be collected for physical examination, eye examination, vital signs, 12-lead electrocardiogram (ECG), Holter monitoring, and clinical laboratory findings at various timepoints throughout the study.
- Conditions
- Healthy, Safety and Tolerability
- Being tested
- DF-003, Placebo
- Keywords
- DF-003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF-003Drug
Oral administration by capsules (1 mg, 5 mg, or 25 mg).
PlaceboDrug
Visually matching 0 mg DF-003 capsules.
| Study group | Role | What they receive |
|---|---|---|
| DF-003 (Single Ascending Dose, Part 1) | Experimental | Participants will receive a single oral dose of 3 mg DF-003 (1 mg x 3). Receives: Drug: DF-003 |
| Placebo (Single Ascending Dose, Part 1) | Placebo comparator | Visually matching 0 mg DF-003 capsules. Receives: Drug: Placebo |
| DF-003 (Multiple Ascending Doses, Part 2) | Experimental | Participants will receive DF-003 once daily by oral administration for 14 days. The specific doses given will be based on data collected in Part 1 of the study. This part of the study may include 1 mg, 5 mg, or 25 mg capsules. Receives: Drug: DF-003 |
| Placebo (Multiple Ascending Doses, Part 2) | Placebo comparator | Visually matching 0 mg DF-003 capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Safety and Tolerability
Measured: Up to 83 days
Incidence of Serious Adverse Events (SAEs)
Safety and Tolerability
Measured: Up to 83 days
Secondary outcomes (15)
Maximum plasma concentration (Cmax) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Time to maximum plasma concentration (tmax) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t)) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Area under the plasma concentration-time curve from zero to infinity ((AUC(0-∞)) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Terminal half-life (t½) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Apparent plasma clearance of drug after extravascular administration (CL/F) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Apparent volume of distribution after extravascular administration (Vz/F) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Maximum plasma concentration at steady state (Cmax,ss) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Time to steady state Cmax (Tss,max) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Concentration at time t (Ct) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Concentration immediately before next dose (Ctrough) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Apparent plasma clearance of drug after extravascular administration at steady state (CLss/F) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Apparent volume of distribution at steady state after extravascular administration (Vz,ss/F) for DF-003
Pharmacokinetics
Measured: Up to 83 days
Accumulation ratio (Rac) at Cmax for DF-003
Pharmacokinetics
Measured: Up to 83 days
Accumulation ratio area under the concentration-time curve for DF-003
Pharmacokinetics
Measured: Up to 83 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start15 Sep 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study will include 2 parts: 1) Single ascending dose phase with optional food effect (FE) assessment, and 2) multiple ascending dose phase.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javid Ghandehari, MD, Principal investigator, Interventional Pain Management Physician Anesthesiologist, Altasciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997641
- Sponsor's protocol ID
- DF-003-1001
- Status last verified
- Jun 2026
- First submitted
- 1 Aug 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hallan SI, Ovrehus MA, Romundstad S, Rifkin D, Langhammer A, Stevens PE, Ix JH. Long-term trends in the prevalence of chronic kidney disease and the influence of cardiovascular risk factors in Norway. Kidney Int. 2016 Sep;90(3):665-73. doi: 10.1016/j.kint.2016.04.012. Epub 2016 Jun 22.
PubMed 27344204Murphy D, McCulloch CE, Lin F, Banerjee T, Bragg-Gresham JL, Eberhardt MS, Morgenstern H, Pavkov ME, Saran R, Powe NR, Hsu CY; Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team. Trends in Prevalence of Chronic Kidney Disease in the United States. Ann Intern Med. 2016 Oct 4;165(7):473-481. doi: 10.7326/M16-0273. Epub 2016 Aug 2.
PubMed 27479614Shin HY, Kang HT. Recent trends in the prevalence of chronic kidney disease in Korean adults: Korean National Health and Nutrition Examination Survey from 1998 to 2013. J Nephrol. 2016 Dec;29(6):799-807. doi: 10.1007/s40620-016-0280-y. Epub 2016 Mar 4.
PubMed 26943182Decleves AE, Sharma K. Novel targets of antifibrotic and anti-inflammatory treatment in CKD. Nat Rev Nephrol. 2014 May;10(5):257-67. doi: 10.1038/nrneph.2014.31. Epub 2014 Mar 25.
PubMed 24662433Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
PubMed 23727169Lopez-Novoa JM, Martinez-Salgado C, Rodriguez-Pena AB, Lopez-Hernandez FJ. Common pathophysiological mechanisms of chronic kidney disease: therapeutic perspectives. Pharmacol Ther. 2010 Oct;128(1):61-81. doi: 10.1016/j.pharmthera.2010.05.006. Epub 2010 Jun 19.
PubMed 20600306Khwaja A, El Kossi M, Floege J, El Nahas M. The management of CKD: a look into the future. Kidney Int. 2007 Dec;72(11):1316-23. doi: 10.1038/sj.ki.5002489. Epub 2007 Aug 15.
PubMed 17700639Liu Y. Cellular and molecular mechanisms of renal fibrosis. Nat Rev Nephrol. 2011 Oct 18;7(12):684-96. doi: 10.1038/nrneph.2011.149.
PubMed 22009250Yu J, Mao S, Zhang Y, Gong W, Jia Z, Huang S, Zhang A. MnTBAP Therapy Attenuates Renal Fibrosis in Mice with 5/6 Nephrectomy. Oxid Med Cell Longev. 2016;2016:7496930. doi: 10.1155/2016/7496930. Epub 2016 Feb 17.
PubMed 26989454Humphreys BD. Mechanisms of Renal Fibrosis. Annu Rev Physiol. 2018 Feb 10;80:309-326. doi: 10.1146/annurev-physiol-022516-034227. Epub 2017 Oct 25.
PubMed 29068765Kefaloyianni E, Muthu ML, Kaeppler J, Sun X, Sabbisetti V, Chalaris A, Rose-John S, Wong E, Sagi I, Waikar SS, Rennke H, Humphreys BD, Bonventre JV, Herrlich A. ADAM17 substrate release in proximal tubule drives kidney fibrosis. JCI Insight. 2016 Aug 18;1(13):e87023. doi: 10.1172/jci.insight.87023.
PubMed 27642633Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.
PubMed 17568785Anders HJ, Belemezova E, Eis V, Segerer S, Vielhauer V, Perez de Lema G, Kretzler M, Cohen CD, Frink M, Horuk R, Hudkins KL, Alpers CE, Mampaso F, Schlondorff D. Late onset of treatment with a chemokine receptor CCR1 antagonist prevents progression of lupus nephritis in MRL-Fas(lpr) mice. J Am Soc Nephrol. 2004 Jun;15(6):1504-13. doi: 10.1097/01.asn.0000130082.67775.60.
PubMed 15153561Duffield JS. Cellular and molecular mechanisms in kidney fibrosis. J Clin Invest. 2014 Jun;124(6):2299-306. doi: 10.1172/JCI72267. Epub 2014 Jun 2.
PubMed 24892703Kurts C, Panzer U, Anders HJ, Rees AJ. The immune system and kidney disease: basic concepts and clinical implications. Nat Rev Immunol. 2013 Oct;13(10):738-53. doi: 10.1038/nri3523. Epub 2013 Sep 16.
PubMed 24037418
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered DF-003 Following Single (Part 1) and Multiple (Part 2) Ascending Doses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05997641
- Acronym / sponsor ID
- DF-003-1001
- Conditions
- Healthy, Safety and Tolerability
- Keywords
- DF-003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics (PK; drug metabolism) of DF-003 after oral administration of single and multiple ascending doses in healthy subjects. The choice of using healthy subjects is standard in establishing the preliminary safety and PK profile of a drug.
DF-003 is a potent small molecule inhibitor of alpha-kinase 1 (ALPK1), which plays an important role in immunity and inflammation. DF-003 can inhibit the immune inflammatory response and has been shown to reduce renal fibrosis in preclinical models. Thus, this study aims to determine the role of DF-003 in the treatment of chronic kidney disease.
This study will include 2 parts. Part 1 is a single ascending dose (SAD) phase with an optional food effect (FE) assessment, while Part 2 is a multiple ascending dose (MAD) phase. Part 1 - SAD Phase with optional FE assessment will include approximately 64 subjects (up to 8 cohorts of 8 subjects each) and Part 2 - MAD Phase will include approximately 32 subjects (up to 4 cohorts of 8 subjects each). Therefore, up to 96 subjects will be included in the study.
Study participants will be screened approximately 42 days within the first scheduled administration of study medication. Screening data will be reviewed to determine subject eligibility. In Part 1, subjects will be randomly assigned to receive a single oral dose of DF-003 (3 x 1 milligram capsules) or matching placebo. The doses to be evaluated in Part 2 will be determined based on review of the available safety and PK data from Part 1.
Subjects will be monitored for adverse events (AEs) and data will be collected for physical examination, eye examination, vital signs, 12-lead electrocardiogram (ECG), Holter monitoring, and clinical laboratory findings at various timepoints throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- The study will include 2 parts: 1) Single ascending dose phase with optional food effect (FE) assessment, and 2) multiple ascending dose phase.
| Arm | Type | Receives |
|---|---|---|
| DF-003 (Single Ascending Dose, Part 1) | Experimental | Drug: DF-003Participants will receive a single oral dose of 3 mg DF-003 (1 mg x 3). |
| Placebo (Single Ascending Dose, Part 1) | Placebo comparator | Drug: PlaceboVisually matching 0 mg DF-003 capsules. |
| DF-003 (Multiple Ascending Doses, Part 2) | Experimental | Drug: DF-003Participants will receive DF-003 once daily by oral administration for 14 days. The specific doses given will be based on data collected in Part 1 of the study. This part of the study may include 1 mg, 5 mg, or 25 mg capsules. |
| Placebo (Multiple Ascending Doses, Part 2) | Placebo comparator | Drug: PlaceboVisually matching 0 mg DF-003 capsules. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Provision of signed and dated informed consent form (ICF).
- Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study, and likeliness to complete the study as planned, per the Investigator's opinion.
- Healthy adult male or female.
- If male, meets one of the following criteria:
- If female, meets one of the following criteria:
Key exclusion criteria (29 listed)
- Female who is lactating.
- Female who is pregnant according to the pregnancy test at Screening or prior to the first study drug administration
- Female using the following systemic contraceptives: oral, patch or vaginal ring, in the 28 days prior to the first study drug administration.
- Female using hormone replacement therapy in the 28 days prior to the first study drug administration.
- Female using the following systemic contraceptives: injections or implant, or hormone-releasing intrauterine device in the 13 weeks prior to the first study drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DF-003Oral administration by capsules (1 mg, 5 mg, or 25 mg). | Drug | DF-003 (Multiple Ascending Doses, Part 2), DF-003 (Single Ascending Dose, Part 1) |
| PlaceboVisually matching 0 mg DF-003 capsules. | Drug | Placebo (Multiple Ascending Doses, Part 2), Placebo (Single Ascending Dose, Part 1) |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 83 days
Safety and Tolerability
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 83 days
Safety and Tolerability
15 secondary outcomes
Maximum plasma concentration (Cmax) for DF-003
Time frame: Up to 83 days
Time to maximum plasma concentration (tmax) for DF-003
Time frame: Up to 83 days
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t)) for DF-003
Time frame: Up to 83 days
Area under the plasma concentration-time curve from zero to infinity ((AUC(0-∞)) for DF-003
Time frame: Up to 83 days
Terminal half-life (t½) for DF-003
Time frame: Up to 83 days
Apparent plasma clearance of drug after extravascular administration (CL/F) for DF-003
Time frame: Up to 83 days
Apparent volume of distribution after extravascular administration (Vz/F) for DF-003
Time frame: Up to 83 days
Maximum plasma concentration at steady state (Cmax,ss) for DF-003
Time frame: Up to 83 days
Time to steady state Cmax (Tss,max) for DF-003
Time frame: Up to 83 days
Concentration at time t (Ct) for DF-003
Time frame: Up to 83 days
Concentration immediately before next dose (Ctrough) for DF-003
Time frame: Up to 83 days
Apparent plasma clearance of drug after extravascular administration at steady state (CLss/F) for DF-003
Time frame: Up to 83 days
Apparent volume of distribution at steady state after extravascular administration (Vz,ss/F) for DF-003
Time frame: Up to 83 days
Accumulation ratio (Rac) at Cmax for DF-003
Time frame: Up to 83 days
Accumulation ratio area under the concentration-time curve for DF-003
Time frame: Up to 83 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 27344204Hallan SI, Ovrehus MA, Romundstad S, Rifkin D, Langhammer A, Stevens PE, Ix JH. Long-term trends in the prevalence of chronic kidney disease and the influence of cardiovascular risk factors in Norway. Kidney Int. 2016 Sep;90(3):665-73. doi: 10.1016/j.kint.2016.04.012. Epub 2016 Jun 22.
- Background: PubMed 27479614Murphy D, McCulloch CE, Lin F, Banerjee T, Bragg-Gresham JL, Eberhardt MS, Morgenstern H, Pavkov ME, Saran R, Powe NR, Hsu CY; Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team. Trends in Prevalence of Chronic Kidney Disease in the United States. Ann Intern Med. 2016 Oct 4;165(7):473-481. doi: 10.7326/M16-0273. Epub 2016 Aug 2.
- Background: PubMed 26943182Shin HY, Kang HT. Recent trends in the prevalence of chronic kidney disease in Korean adults: Korean National Health and Nutrition Examination Survey from 1998 to 2013. J Nephrol. 2016 Dec;29(6):799-807. doi: 10.1007/s40620-016-0280-y. Epub 2016 Mar 4.
- Background: PubMed 24662433Decleves AE, Sharma K. Novel targets of antifibrotic and anti-inflammatory treatment in CKD. Nat Rev Nephrol. 2014 May;10(5):257-67. doi: 10.1038/nrneph.2014.31. Epub 2014 Mar 25.
- Background: PubMed 23727169Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
- Background: PubMed 20600306Lopez-Novoa JM, Martinez-Salgado C, Rodriguez-Pena AB, Lopez-Hernandez FJ. Common pathophysiological mechanisms of chronic kidney disease: therapeutic perspectives. Pharmacol Ther. 2010 Oct;128(1):61-81. doi: 10.1016/j.pharmthera.2010.05.006. Epub 2010 Jun 19.
- Background: PubMed 17700639Khwaja A, El Kossi M, Floege J, El Nahas M. The management of CKD: a look into the future. Kidney Int. 2007 Dec;72(11):1316-23. doi: 10.1038/sj.ki.5002489. Epub 2007 Aug 15.
- Background: PubMed 22009250Liu Y. Cellular and molecular mechanisms of renal fibrosis. Nat Rev Nephrol. 2011 Oct 18;7(12):684-96. doi: 10.1038/nrneph.2011.149.
- Background: PubMed 26989454Yu J, Mao S, Zhang Y, Gong W, Jia Z, Huang S, Zhang A. MnTBAP Therapy Attenuates Renal Fibrosis in Mice with 5/6 Nephrectomy. Oxid Med Cell Longev. 2016;2016:7496930. doi: 10.1155/2016/7496930. Epub 2016 Feb 17.
- Background: PubMed 29068765Humphreys BD. Mechanisms of Renal Fibrosis. Annu Rev Physiol. 2018 Feb 10;80:309-326. doi: 10.1146/annurev-physiol-022516-034227. Epub 2017 Oct 25.
- Background: PubMed 27642633Kefaloyianni E, Muthu ML, Kaeppler J, Sun X, Sabbisetti V, Chalaris A, Rose-John S, Wong E, Sagi I, Waikar SS, Rennke H, Humphreys BD, Bonventre JV, Herrlich A. ADAM17 substrate release in proximal tubule drives kidney fibrosis. JCI Insight. 2016 Aug 18;1(13):e87023. doi: 10.1172/jci.insight.87023.
- Background: PubMed 17568785Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.
- CenChronic Kidney Disease in the United States, 2021. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javid Ghandehari, MD principal investigator
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1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DF-003 in people with Healthy and Safety and Tolerability, run by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Up to 83 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997641, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.