CachexiaPhase 1NCT04815551
A Phase 1 Study of AV-380 in Healthy Subjects
A Phase 1 study testing AV-380 in people with Cachexia, run by AVEO Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cachexia
- What is being tested?
- AV-380
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 14 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers, 18 to 50 years of age, inclusive.
- A body mass index (BMI) between 18 and 30 kg/m2 and weight between 60 and 90 kg.
- Healthy as indicated by a comprehensive clinical assessment (detailed medical history and complete physical examination). Supine blood pressure (BP), heart rate (HR), electrocardiogram (ECG) intervals and routine laboratory tests within the normal range of the study center (see Appendix 4) or considered not clinically significant by the Investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin must be < 1.5 times the upper limit of the normal range (ULN). Total bilirubin, if above 1.5 x ULN, is only acceptable with a history of Gilbert's Syndrome.
- Non-smoker or ex-smoker for longer than 6 months.
- Sexually active pre-menopausal female subjects and female partners of male subjects must use adequate contraceptive measures, while on study and for at least 100 days after the IMP administration. Sexually active male subjects must use adequate contraceptive measures, while on study and for at least 160 days after the last dose of IMP. All fertile male and female subjects and their partners must agree to use a highly effective method of contraception. Effective birth control includes hormonal contraception (oral, intravaginal, transdermal, injectable or implantable), intrauterine device (IUD) plus one barrier method; or 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). Vasectomy (at least 3 months before IMP administration) and vasectomized partner (provided that the partner is the sole sexual partner of the trial participant and that the absence of sperm in the ejaculate has been confirmed) are acceptable methods of contraception, as well as post-menopausal female for at least 1 year (confirmed with serum follicle stimulating hormone [FSH] > 25.8 IU/L at screening), or surgically sterilized female subjects. Abstinence is not an acceptable contraception method. Female subjects who are of non-childbearing potential due to a surgical procedure or medical condition must provide documentation, and vasectomized male subjects must bring in the surgical report of the procedure.
- Able to sign and understand an ICF and able to comply with study restrictions prior to selection.
Who cannot join
- Presence or history of any disorder that may prevent the successful completion of the study.
- Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), such as:
- White blood cell count < 3.0x109/L.
- Neutrophils < 1.5x109/L or clinically abnormal according to the subject's ethnic group (must be > 1.0x109/L for subjects of African descent).
- Hemoglobin < 10 g/dL.
- Platelet count < 125x109/L or > 450x109/L.
Show all 30Show fewer
- ALT > 1.5 ULN.
- AST > 1.5 ULN.
- Total bilirubin > 1.5 ULN (except in the presence of Gilbert's syndrome).
- Creatinine > 1.2 ULN.
- Sodium < 132 mmol/L or > 147 mmol/L.
- Potassium < 3.2 mmol/L or > 5.5 mmol/L.
- Chloride < 93 mmol/L or > 111 mmol/L.
- Calcium < 8.3 mmol/L or > 10.7 mmol/L. Clinically significant abnormal values for all other laboratory parameters are at the investigator's discretion.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational medicine product.
- Any history of drug related hypersensitivity reaction.
- Prior treatment with a monoclonal antibody.
- Intercurrent illness as evidenced by, e.g., nausea, vomiting, fever, or diarrhea) within 7 days before D1.
- History of drug abuse (habitual taking of addictive or illegal drugs) within 1 year before D1.
- Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or grapefruit-containing products or alcoholic beverages within 48 hours before D1 and until D7.
- Any condition or disease detected during the medical interview / physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator or his designee.
- Frequent headaches and/or migraine, recurrent nausea and / or vomiting.
- Female subjects who are pregnant, or breastfeeding.
- Positive screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, phencyclidine [PCP]) and breath alcohol test at screening or D-2.
- Positive serology for hepatitis B or hepatitis C or human immunodeficiency viruses (HIV).
- Positive SARS-CoV-2 RT-PCR.
- Any condition detected at screening that may interfere with or bias the physical examinations to be performed during the study.
- Any prescribed or over-the-counter medication or herbal products taken within 1 week prior to start of administration of IMP (D1) or within 6 times the elimination half-life of the medication prior to start of IMP intake (whichever is longer), except birth control as described in inclusion criterion number 5 in Section 6.1. Vitamin/mineral supplements and occasional use of acetaminophen is allowed up until 24 hours before dosing.
- Participation in a clinical trial or use of an investigational drug within 30 days before randomization.
- Any vaccination within 30 days before signature of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, First-in-human, Randomized, Placebo Controlled, Double Blind, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AV-380 in Healthy Subjects
This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
- Conditions
- Cachexia
- Being tested
- AV-380, Placebo
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-380Drug
AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
PlaceboDrug
Placebo is sterile liquid for IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| AV-380 IV 4 mg/kg | Experimental | IV infusion of AV-380 at dose level 4 mg/kg Receives: Drug: AV-380 |
| AV-380 IV 8 mg/kg | Experimental | IV infusion of AV-380 at dose level 8 mg/kg Receives: Drug: AV-380 |
| AV-380 IV 13 mg/kg | Experimental | IV infusion of AV-380 at dose level 13 mg/kg Receives: Drug: AV-380 |
| AV-380 IV 20 mg/kg | Experimental | IV infusion of AV-380 at dose level 20 mg/kg Receives: Drug: AV-380 |
| AV-380 SC 4 mg/kg | Experimental | Subcutaneous injection of AV-380 at dose level 4 mg/kg Receives: Drug: AV-380 |
| AV-380 SC 2 mg/kg | Experimental | Subcutaneous injection of AV-380 at dose level 2 mg/kg Receives: Drug: AV-380 |
| AV-380 SC 1 mg/kg | Experimental | Subcutaneous injection of AV-380 at dose level 1 mg/kg Receives: Drug: AV-380 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events (AEs) and treatment emergent adverse events (TEAEs)
Measured: Through study completion, an average of 60 days
Injection site safety and tolerability assessment
Site injection tolerability will be assessed by the Investigator using a 4-level score (none, mild, moderate, severe) after IV infusion and SC injection.
Measured: Visit Day 1
Clinical laboratory measurements - Hematology - hemoglobin
Hemoglobin (g/dL)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Hematology - hematocrit
Hematocrit (%)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Hematology - erythrocytes
Erythrocytes
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Hematology - white blood cell count
White blood cell count with differential (neutrophils, basophils, eosinophils, lymphocytes, monocytes and platelets) (X10(3)/UL)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - sodium
Sodium (mmol/L)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - potassium
Potassium (mmol/L)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - calcium
Calcium (mg/dL)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - chloride
Chloride (mmol/L)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - CO2
CO2 (mmol/L)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - blood urea nitrogen
Blood urea nitrogen (mg/dl)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - creatinine
creatinine (mg/dL), glucose, total proteins, triglycerides, total cholesterol, AST, ALT, gamma-glutamyltransferase, creatinine phosphokinase, albumin, alkaline phosphatase, and total bilirubin
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - glucose
Glucose (mg/dL)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - total proteins
Total proteins (g/dL), triglycerides, total cholesterol, AST, ALT, gamma-glutamyltransferase, creatinine phosphokinase, albumin, alkaline phosphatase, and total bilirubin
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - triglycerides
Triglycerides (mg/dL)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - total cholesterol
Total cholesterol (mg/dL)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - AST
AST (U/L)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - ALT
ALT (U/L)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - Gamma-glutamyltransferase
Gamma-glutamyltransferase (U/L)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - Creatinine phosphokinase
Creatinine phosphokinase (mg/dL)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - albumin
Albumin (g/dL)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - alkaline phosphatase
Alkaline phosphatase (U/L)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Blood chemistry - total bilirubin
Total bilirubin (mg/dl)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Coagulation - partial thromboplastin time
Activated partial thromboplastin time (secs)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Coagulation - prothrombin time
Prothrombin time (sec)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Coagulation - International normalized ratio
International normalized ratio
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Hormonology
Measured parameters: Hormonology (TSH, FSH (for post-menopausal women); β-HCG (for women of childbearing potential))
Measured: Visits Day 1 through Day 90
Clinical laboratory measurements - Hormonology - TSH
TSH (mIU/mL)
Measured: Visits Day 1 through Day 90
Clinical laboratory measurements - Hormonology - FSH
FSH (mIU/mL)
Measured: Visits Day 1 through Day 90
Clinical laboratory measurements - Urinalysis - pH
pH
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Urinalysis - protein
Protein (negative/positive)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Urinalysis - glucose
Glucose (negative/positive)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Urinalysis - leukocytes
Leukocytes (negative/positive)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Urinalysis - nitrites
Nitrites (negative/positive)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Urinalysis - ketones
Ketones (negative/positive)
Measured: Visits Day 1 through Day 60
Clinical laboratory measurements - Urinalysis - blood
Blood (negative/positive)
Measured: Visits Day 1 through Day 60
Vital signs measurements - Blood pressure
Supine and standing systolic and diastolic blood pressure (mmHg)
Measured: Visits Day 1 through Day 90
Vital signs measurements - Heart rate
Heart rate (beats/min)
Measured: Visits Day 1 through Day 90
Vital signs measurements - Body temperature
Body temperature (degrees Celsius)
Measured: Visits Day 1 through Day 90
Vital signs measurements - Respiratory rate
Respiratory rate (breaths/min)
Measured: Visits Day 1 through Day 90
Electrocardiogram (ECG) measurements - Mean heart rate
ECG mean heart rate (beats/min)
Measured: Visits Day 1 through Day 90
Electrocardiogram (ECG) measurements - PR interval
PR interval, aggregate (msec)
Measured: Visits Day 1 through Day 90
Electrocardiogram (ECG) measurements - QRS axis
QRS axis (deg)
Measured: Visits Day 1 through Day 90
Electrocardiogram (ECG) measurements - QTcF interval
QTcF interval, aggregate (msec)
Measured: Visits Day 1 through Day 90
Secondary outcomes (7)
Serum PK of single dose AV-380 via intravenous infusion and subcutaneous injection
Cmax (maximum observed serum concentration)
Measured: Visits Day 1 through D90
Serum PK of single dose AV-380 via intravenous infusion and subcutaneous injection
Tmax (time to reach maximum serum concentration)
Measured: Visits Day 1 through Day 90
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
Emax (maximum effect observed)
Measured: Visits Day 1 through Day 90
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
AUEC (area under the effect-time curve)
Measured: Visits Day 1 through Day 90
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
TEmax (time to reach maximum effect)
Measured: Visits Day 1 through Day 90
AV-380 immunogenicity in healthy subjects - anti-AV-380 antibodies (human anti-human antibodies [HAHA]) levels in serum.
HAHA levels
Measured: Visits Day 1 through Day 180
AV-380 immunogenicity in healthy subjects - Monocyte chemoattractant protein 1 (MCP-1) levels in serum.
Serum MCP-1 levels will be measured.
Measured: Visits Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Feb 2021
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815551
- Sponsor's protocol ID
- AV-380-20-101
- Status last verified
- Jun 2023
- First submitted
- 8 Mar 2021
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human, Randomized, Placebo Controlled, Double Blind, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AV-380 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04815551
- Acronym / sponsor ID
- AV-380-20-101
- Conditions
- Cachexia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 25 Mar 2021 (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.
This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| AV-380 IV 4 mg/kg | Experimental | Drug: AV-380IV infusion of AV-380 at dose level 4 mg/kg |
| AV-380 IV 8 mg/kg | Experimental | Drug: AV-380IV infusion of AV-380 at dose level 8 mg/kg |
| AV-380 IV 13 mg/kg | Experimental | Drug: AV-380IV infusion of AV-380 at dose level 13 mg/kg |
| AV-380 IV 20 mg/kg | Experimental | Drug: AV-380IV infusion of AV-380 at dose level 20 mg/kg |
| AV-380 SC 4 mg/kg | Experimental | Drug: AV-380Subcutaneous injection of AV-380 at dose level 4 mg/kg |
| AV-380 SC 2 mg/kg | Experimental | Drug: AV-380Subcutaneous injection of AV-380 at dose level 2 mg/kg |
| AV-380 SC 1 mg/kg | Experimental | Drug: AV-380Subcutaneous injection of AV-380 at dose level 1 mg/kg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and female volunteers, 18 to 50 years of age, inclusive.
- A body mass index (BMI) between 18 and 30 kg/m2 and weight between 60 and 90 kg.
- Healthy as indicated by a comprehensive clinical assessment (detailed medical history and complete physical examination). Supine blood pressure (BP), heart rate (HR), electrocardiogram (ECG) intervals and routine laboratory tests within the normal range of the study center (see Appendix 4) or considered not clinically significant by the Investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin must be < 1.5 times the upper limit of the normal range (ULN). Total bilirubin, if above 1.5 x ULN, is only acceptable with a history of Gilbert's Syndrome.
- Non-smoker or ex-smoker for longer than 6 months.
- Sexually active pre-menopausal female subjects and female partners of male subjects must use adequate contraceptive measures, while on study and for at least 100 days after the IMP administration. Sexually active male subjects must use adequate contraceptive measures, while on study and for at least 160 days after the last dose of IMP. All fertile male and female subjects and their partners must agree to use a highly effective method of contraception. Effective birth control includes hormonal contraception (oral, intravaginal, transdermal, injectable or implantable), intrauterine device (IUD) plus one barrier method; or 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). Vasectomy (at least 3 months before IMP administration) and vasectomized partner (provided that the partner is the sole sexual partner of the trial participant and that the absence of sperm in the ejaculate has been confirmed) are acceptable methods of contraception, as well as post-menopausal female for at least 1 year (confirmed with serum follicle stimulating hormone [FSH] > 25.8 IU/L at screening), or surgically sterilized female subjects. Abstinence is not an acceptable contraception method. Female subjects who are of non-childbearing potential due to a surgical procedure or medical condition must provide documentation, and vasectomized male subjects must bring in the surgical report of the procedure.
Key exclusion criteria (30 listed)
- Presence or history of any disorder that may prevent the successful completion of the study.
- Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), such as:
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational medicine product.
- Any history of drug related hypersensitivity reaction.
- Prior treatment with a monoclonal antibody.
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 |
|---|---|---|
| AV-380AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia. | Drug | AV-380 IV 13 mg/kg, AV-380 IV 20 mg/kg, AV-380 IV 4 mg/kg, AV-380 IV 8 mg/kg, AV-380 SC 1 mg/kg, AV-380 SC 2 mg/kg, AV-380 SC 4 mg/kg |
| PlaceboPlacebo is sterile liquid for IV infusion. | Drug | Placebo |
Primary outcome
Assessment of adverse events (AEs) and treatment emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 60 days
Injection site safety and tolerability assessment
Time frame: Visit Day 1
Site injection tolerability will be assessed by the Investigator using a 4-level score (none, mild, moderate, severe) after IV infusion and SC injection.
Clinical laboratory measurements - Hematology - hemoglobin
Time frame: Visits Day 1 through Day 60
Hemoglobin (g/dL)
Clinical laboratory measurements - Hematology - hematocrit
Time frame: Visits Day 1 through Day 60
Hematocrit (%)
Clinical laboratory measurements - Hematology - erythrocytes
Time frame: Visits Day 1 through Day 60
Erythrocytes
Clinical laboratory measurements - Hematology - white blood cell count
Time frame: Visits Day 1 through Day 60
White blood cell count with differential (neutrophils, basophils, eosinophils, lymphocytes, monocytes and platelets) (X10(3)/UL)
Clinical laboratory measurements - Blood chemistry - sodium
Time frame: Visits Day 1 through Day 60
Sodium (mmol/L)
Clinical laboratory measurements - Blood chemistry - potassium
Time frame: Visits Day 1 through Day 60
Potassium (mmol/L)
Clinical laboratory measurements - Blood chemistry - calcium
Time frame: Visits Day 1 through Day 60
Calcium (mg/dL)
Clinical laboratory measurements - Blood chemistry - chloride
Time frame: Visits Day 1 through Day 60
Chloride (mmol/L)
Clinical laboratory measurements - Blood chemistry - CO2
Time frame: Visits Day 1 through Day 60
CO2 (mmol/L)
Clinical laboratory measurements - Blood chemistry - blood urea nitrogen
Time frame: Visits Day 1 through Day 60
Blood urea nitrogen (mg/dl)
Clinical laboratory measurements - Blood chemistry - creatinine
Time frame: Visits Day 1 through Day 60
creatinine (mg/dL), glucose, total proteins, triglycerides, total cholesterol, AST, ALT, gamma-glutamyltransferase, creatinine phosphokinase, albumin, alkaline phosphatase, and total bilirubin
Clinical laboratory measurements - Blood chemistry - glucose
Time frame: Visits Day 1 through Day 60
Glucose (mg/dL)
Clinical laboratory measurements - Blood chemistry - total proteins
Time frame: Visits Day 1 through Day 60
Total proteins (g/dL), triglycerides, total cholesterol, AST, ALT, gamma-glutamyltransferase, creatinine phosphokinase, albumin, alkaline phosphatase, and total bilirubin
Clinical laboratory measurements - Blood chemistry - triglycerides
Time frame: Visits Day 1 through Day 60
Triglycerides (mg/dL)
Clinical laboratory measurements - Blood chemistry - total cholesterol
Time frame: Visits Day 1 through Day 60
Total cholesterol (mg/dL)
Clinical laboratory measurements - Blood chemistry - AST
Time frame: Visits Day 1 through Day 60
AST (U/L)
Clinical laboratory measurements - Blood chemistry - ALT
Time frame: Visits Day 1 through Day 60
ALT (U/L)
Clinical laboratory measurements - Blood chemistry - Gamma-glutamyltransferase
Time frame: Visits Day 1 through Day 60
Gamma-glutamyltransferase (U/L)
Clinical laboratory measurements - Blood chemistry - Creatinine phosphokinase
Time frame: Visits Day 1 through Day 60
Creatinine phosphokinase (mg/dL)
Clinical laboratory measurements - Blood chemistry - albumin
Time frame: Visits Day 1 through Day 60
Albumin (g/dL)
Clinical laboratory measurements - Blood chemistry - alkaline phosphatase
Time frame: Visits Day 1 through Day 60
Alkaline phosphatase (U/L)
Clinical laboratory measurements - Blood chemistry - total bilirubin
Time frame: Visits Day 1 through Day 60
Total bilirubin (mg/dl)
Clinical laboratory measurements - Coagulation - partial thromboplastin time
Time frame: Visits Day 1 through Day 60
Activated partial thromboplastin time (secs)
Clinical laboratory measurements - Coagulation - prothrombin time
Time frame: Visits Day 1 through Day 60
Prothrombin time (sec)
Clinical laboratory measurements - Coagulation - International normalized ratio
Time frame: Visits Day 1 through Day 60
International normalized ratio
Clinical laboratory measurements - Hormonology
Time frame: Visits Day 1 through Day 90
Measured parameters: Hormonology (TSH, FSH (for post-menopausal women); β-HCG (for women of childbearing potential))
Clinical laboratory measurements - Hormonology - TSH
Time frame: Visits Day 1 through Day 90
TSH (mIU/mL)
Clinical laboratory measurements - Hormonology - FSH
Time frame: Visits Day 1 through Day 90
FSH (mIU/mL)
Clinical laboratory measurements - Urinalysis - pH
Time frame: Visits Day 1 through Day 60
pH
Clinical laboratory measurements - Urinalysis - protein
Time frame: Visits Day 1 through Day 60
Protein (negative/positive)
Clinical laboratory measurements - Urinalysis - glucose
Time frame: Visits Day 1 through Day 60
Glucose (negative/positive)
Clinical laboratory measurements - Urinalysis - leukocytes
Time frame: Visits Day 1 through Day 60
Leukocytes (negative/positive)
Clinical laboratory measurements - Urinalysis - nitrites
Time frame: Visits Day 1 through Day 60
Nitrites (negative/positive)
Clinical laboratory measurements - Urinalysis - ketones
Time frame: Visits Day 1 through Day 60
Ketones (negative/positive)
Clinical laboratory measurements - Urinalysis - blood
Time frame: Visits Day 1 through Day 60
Blood (negative/positive)
Vital signs measurements - Blood pressure
Time frame: Visits Day 1 through Day 90
Supine and standing systolic and diastolic blood pressure (mmHg)
Vital signs measurements - Heart rate
Time frame: Visits Day 1 through Day 90
Heart rate (beats/min)
Vital signs measurements - Body temperature
Time frame: Visits Day 1 through Day 90
Body temperature (degrees Celsius)
Vital signs measurements - Respiratory rate
Time frame: Visits Day 1 through Day 90
Respiratory rate (breaths/min)
Electrocardiogram (ECG) measurements - Mean heart rate
Time frame: Visits Day 1 through Day 90
ECG mean heart rate (beats/min)
Electrocardiogram (ECG) measurements - PR interval
Time frame: Visits Day 1 through Day 90
PR interval, aggregate (msec)
Electrocardiogram (ECG) measurements - QRS axis
Time frame: Visits Day 1 through Day 90
QRS axis (deg)
Electrocardiogram (ECG) measurements - QTcF interval
Time frame: Visits Day 1 through Day 90
QTcF interval, aggregate (msec)
7 secondary outcomes
Serum PK of single dose AV-380 via intravenous infusion and subcutaneous injection
Time frame: Visits Day 1 through D90
Serum PK of single dose AV-380 via intravenous infusion and subcutaneous injection
Time frame: Visits Day 1 through Day 90
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
Time frame: Visits Day 1 through Day 90
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
Time frame: Visits Day 1 through Day 90
To correlate the serum level of GDF-15 with the dose and serum level of AV-380
Time frame: Visits Day 1 through Day 90
AV-380 immunogenicity in healthy subjects - anti-AV-380 antibodies (human anti-human antibodies [HAHA]) levels in serum.
Time frame: Visits Day 1 through Day 180
AV-380 immunogenicity in healthy subjects - Monocyte chemoattractant protein 1 (MCP-1) levels in serum.
Time frame: Visits Day 1 and Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 AV-380 in people with Cachexia, run by AVEO Pharmaceuticals, Inc. 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 6 inclusion and 30 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: finished, as of the sponsor's last update on 12 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of adverse events (AEs) and treatment emergent adverse events (TEAEs) (time frame: Through study completion, an average of 60 days). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2023.