COVID-19Phase 1NCT06146374
Safety Study of SLV213 for the Treatment of COVID-19.
A Phase 1 study testing SLV213 in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This Phase 1 double blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses (MAD) of SLV213 in healthy male and female participants, 18-65 years of age. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- SLV213
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2024to 8 Jul 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Able to understand and willing to be available for all study visits and comply with all study procedures including Lifestyle Considerations throughout the study.
- Male and Female individuals, age 18-65 inclusive at time of enrollment.
- Good general health by medical history (MH), physical examination (PE), and vital signs (VS), clinical laboratory tests and Electrocardiogram (ECG) within normal reference range.
- Note 1: Lab exceptions include: lab test values that are within Grade 1 range per the Toxicity Table (Appendix A) are acceptable if not considered to be clinically significant by the investigator (PI, sub-investigator, or authorized clinician), with the exception of liver function tests (LFT) (transaminases Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), alkaline phosphatase (AP), total and direct bilirubin, serum creatinine, estimated glomerular filtration rate (eGFR) per the CKD-EPI formula, and urine protein, which must be within the laboratory normal reference range.
- Note 2: Screening laboratory values that fall outside the laboratory normal reference ranges and the ranges are not listed within the Toxicity Table (Appendix A) (e.g., decrease activated partial thromboplastin time (aPTT)) that are deemed Not Clinically Significant by the PI will be acceptable.
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- Ability to take oral medication and be willing to adhere to the dosing regimen.
- Women of childbearing potential1 must have practiced or use true abstinence2 or use at least one acceptable primary form of contraception3 for specified periods4 before, during and after dosing.
- Note 1: Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, salpingectomy, tubal ligation, or Essure placement with a history of documented radiological confirmation test at least 90 days after the procedure).
- Note 2: True abstinence is 100% of the time without sexual intercourse (the male's penis enters the female's vagina). Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
- Note 3: Acceptable forms of primary contraception include a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more before the participant receiving the study product, tubal ligation, non-hormonal, intrauterine device, (and if in a monogamous relationship with a male partner who uses a barrier method without spermicide) Note 4: Specified periods include at least 30 days prior to screening, during the period between screening and completion of dosing, and until at least 30 days following receipt of the last dose of study product.
- Women of childbearing potential must have a negative serum Beta-human chorionic gonadotropin (HCG) pregnancy test at screening and a negative urine HCG pregnancy test at check-in (Day-1) within 24 hours before receiving the initial study product.
- Male participants receiving the study product must use acceptable contraception and refrain from donating sperm from the day of first dose until 30 days after the last dose or be vasectomized.1 Note 1: Acceptable contraception includes abstinence from intercourse with a female of childbearing potential or use of a male condom without spermicide when engaging in any activity that allows for the passage of ejaculate to a female during the intervention period and for at least 30 days after ending study dosing, or surgical sterilization for 180 days or more.
- Willing to avoid excessive physical exercise starting within 48 h prior to dosing and until discharge from the CTU on Day 9.
- No history of acute febrile or infectious illness for at least 7 days prior to the administration of study drug.
Who cannot join
- Pregnant or lactating.
- History of any chronic disease that may increase risk to subject or interfere with endpoint assessment1:
- Note 1: With the exception of stable chronic medical conditions that do not require prescribed oral or injectable medications (e.g., Type 2 diabetes managed by diet only).
- History of bradycardia, orthostatic hypotension or orthostatic tachycardia, Long COVID or history of dysautonomia.1 Note 1: Exception is sinus bradycardia (HR <60 bpm) in healthy participants (e.g., conditioned athletes) could be enrolled per investigator's clinical judgement.
- Known history of a clinically significant food or drug allergy/hypersensitivity including known allergy/hypersensitivity to ingredients of the study drug or placebo.
- Current seasonal allergies with ongoing symptoms for more than a week prior to dosing requiring glucocorticoids and/or frequent use of antihistamines for treatment.
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- History of any clinically significant disease or disorder, medical/surgical procedure, or trauma within 4 weeks prior to initiation of administration of study product(s).
- History of any psychiatric condition that has required hospitalization in the last 12 months or subject is considered psychologically unstable by the investigator.
- History of any substance use disorder or positive urine drug screening (UDS) test for illicit substances at Screening or Check-in (Day -1)1.
- Note 1: Any approved medical use of amphetamines, barbiturates, benzodiazepines, cannabis, tricyclic antidepressants and opiates will not be acceptable.
- History of alcoholism or of binge1 or heavy alcohol drinking2 at any time in the 6 months before study product administration or positive urine alcohol test at Screening or Check-in (Day -1).
- Note 1: Binge drinking is defined as 5 or more drinks during a single occasion if male, or 4 or more if female.
- Note 2: Heavy drinking of alcohol is defined as consumption of more than 14 drinks of alcohol per week if male, or more than 7 drinks if female.
- History of >/=10 pack-years of nicotine product1 consumption in the 5-year period before screening, or positive urine cotinine screen at Check-in (Day -1)2.
- Note 1: Nicotine products include cigarettes, e-cigarettes, pipe, cigar, chewing tobacco, nicotine patch.
- Note 2: Positive urine cotinine at Screening is allowed if negative at Check-in (Day -1).
- Body mass index (BMI) </= 18 kg/m2 or >/= 32 kg/m2, or weight </= 100 lbs at Screening.
- Prior exposure to SLV213 or K777 or K11777.
- Use of any prohibited prescription or non-prescription medication within 14 days or 5 half-lives of the drug, whichever is longer, prior to study Check-in.
- Use of any investigational drug product within 30 days or 5 half-lives (whichever is longer) before investigational product administration in this study.
- Planned participation in a clinical research study that requires treatment with a study drug, blood draws or other invasive assessments during the study period (screening until final visit).
- Blood or plasma donation of 500 mL within 3 months or more than 100 mL within 30 days before signing informed consent or planned donation prior to completion of this trial.
- Positive viral serology tests for Human Immunodeficiency Virus (HIV), hepatitis B virus, or hepatitis C virus (HCV) at screening1 with one exception2:
- Note 1: Viral serology tests include HIV 1 and HIV 2 antibodies, Hepatitis B virus surface antigen (HBsAg), and HCV antibodies.
- Note 2: Do not exclude participants with HCV antibodies who have been successfully treated for Hepatitis C, do not take any treatment medications currently, do not use prohibited medications, have normal transaminases and are generally healthy.
- Positive SARS-CoV-2 (COVID-19) molecular diagnostic test (Cue Care™ test) at Check-in (Day -1).
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Inc - Kansas City
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose, Phase 1 Study of SLV213 in Healthy Volunteers
This Phase 1 double blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses (MAD) of SLV213 in healthy male and female participants, 18-65 years of age. This study will help to select the most likely suitable dose (e.g., at Maximum Tolerated Dose [MTD]) for the treatment of patients with COVID-19 in a pivotal study. This phase 1 double blind, placebo-controlled study will consist of three sequential cohorts of 12 participants each (8 SLV213 and 4 placebo), at doses of 400 mg every 12 hours (Q12h), 600 mg Q12h, and 800 mg Q12h administered orally (PO) for 7 days. After each cohort, a Safety Review Committee (SRC) will evaluate the safety of the regimen before proceeding to dose the next cohort. Randomization will occur into the respective cohorts as above. Upon meeting the Inclusion/Exclusion criteria, subjects will begin treatment with SLV213 or placebo per their assigned cohort. The primary objective is to evaluate the safety and tolerability of multiple ascending doses of SLV213 for 7 days in healthy participants.
Read the detailed description
This Phase 1 double blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses (MAD) of SLV213 in healthy male and female participants, 18-65 years of age. This study will help to select the most likely suitable dose (e.g., at Maximum Tolerated Dose [MTD]) for the treatment of patients with COVID-19 in a pivotal study. This phase 1 double blind, placebo-controlled study will consist of three sequential cohorts of 12 participants each (8 SLV213 and 4 placebo), at doses of 400 mg every 12 hours (Q12h), 600 mg Q12h, and 800 mg Q12h administered orally (PO) for 7 days. After each cohort, a Safety Review Committee (SRC) will evaluate the safety of the regimen before proceeding to dose the next cohort. Randomization will occur into the respective cohorts as above. Upon meeting the Inclusion/Exclusion criteria, subjects will begin treatment with SLV213 or placebo per their assigned cohort. Participants will take their study drug in the fasted state prior to morning and evening meals and will remain as in-patient in the clinical trial unit (CTU) during all treatments and for approximately 48 hours (h) after the last dose for monitoring. After discharge from the CTU, participants will be monitored by CTU staff by telephone to assess for new adverse events and use of concomitant medication since the last visit or contact, approximately weekly for three weeks. Participants will be asked to return to the CTU for further assessment of moderate or severe adverse events (AEs) use of concomitant medications (ConMeds) since the last visit or contact, approximately weekly for three weeks. The primary objective is to evaluate the safety and tolerability of multiple ascending doses of SLV213 for 7 days in healthy participants. The secondary objective is to characterize the multiple dose PK of SLV213 in healthy participants.
- Conditions
- COVID-19
- Being tested
- Placebo for SLV213, SLV213
- Keywords
- Coronavirus, Covid-19, Double Blind, Healthy Volunteers, Multiple Ascending Dose, Phase 1, Placebo Controlled, Randomized, SLV213
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo for SLV213Other
Microcrystalline cellulose in a size 1 orange hard gelatin capsule.
SLV213Drug
SLV213 drug substance (K777) is 4-methylpiperazine-1-carboxylic acid, a vinyl sulfone cysteine protease inhibitor for the treatment of subjects infected with SARS-CoV-2. SLV213 is a white powder substance without excipients or stabilizer that will be packed into gelatin capsules which has been demonstrated to exhibit broad inhibitory properties against host cathepsins (e.g., Cathepsin L).
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | 600mg (6x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age. Receives: Other: Placebo for SLV213; Drug: SLV213 |
| Group 3 | Experimental | 800mg (8x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age. Receives: Other: Placebo for SLV213; Drug: SLV213 |
| Group1 | Experimental | 400mg (4x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age. Receives: Other: Placebo for SLV213; Drug: SLV213 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Treatment-Emergent Adverse Events (TEAEs) by Maximum Severity
The number of participants who experienced at least one unsolicited TEAE of any relatedness are summarized by the maximum severity recorded. A TEAE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as a TEAE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as a TEAE.
Measured: Day 1 through Day 28
Frequency of Related Treatment-Related TEAEs
The number of participants who experienced at least one related unsolicited TEAE of any severity. A TEAE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as a TEAE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as a TEAE. A TEAE is considered related if there is a reasonable possibility that the study intervention caused the TEAE, or there is a temporal relationship between the study intervention and event.
Measured: Day 1 through Day 28
Frequency of Serious Adverse Events (SAEs)
The number of participants who experienced at least one SAE throughout the course of the study. An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes:
- Death
- A life-threatening adverse event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or
- A congenital anomaly/birth defect.
Measured: Day 1 through Day 28
Frequency of Laboratory AEs by Maximum Severity
The number of participants who experienced at least one laboratory AE of any relatedness are summarized by the maximum severity recorded. Graded chemistry measurements include sodium, potassium, carbon dioxide, calcium, creatinine, blood urea nitrogen, fasting glucose, total protein, albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, amylase, lipase, magnesium, and inorganic phosphorous. Graded hematology measurements include hemoglobin, platelets, white blood cells, neutrophils, lymphocytes, monocytes, basophils, and eosinophils. Graded coagulation measurements include prothrombin time and activated partial thromboplastin time. Graded urinalysis measurements include nitrite, urine protein, urine glucose, white blood cells, red blood cells, and bacteria. If a laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Measured: Day 1 through Day 28
Frequency of Treatment-Related Laboratory AEs
The number of participants who experienced at least one related laboratory AE of any severity. Graded chemistry measurements include sodium, potassium, carbon dioxide, calcium, creatinine, blood urea nitrogen, fasting glucose, total protein, albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, amylase, lipase, magnesium, and inorganic phosphorous. Graded hematology measurements include hemoglobin, platelets, white blood cells, neutrophils, lymphocytes, monocytes, basophils, and eosinophils. Graded coagulation measurements include prothrombin time and activated partial thromboplastin time. Graded urinalysis measurements include nitrite, urine protein, urine glucose, white blood cells, red blood cells, and bacteria. If a laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Measured: Day 1 through Day 28
Frequency of Electrocardiogram (ECG) AEs by Maximum Severity
The number of participants who experienced at least one ECG AE of any relatedness are summarized by the maximum severity recorded. Graded ECG parameters include PR Internal and QTcF Interval.
Measured: Day 1 through Day 28
Frequency of Treatment-Related ECG AEs
The number of participants who experienced at least one related ECG AE of any severity. Graded ECG parameters include PR Internal and QTcF Interval.
Measured: Day 1 through Day 28
Frequency of Early Terminations or Withdrawals Due to Treatment-Related TEAEs
The number of participants who terminated early or were withdrawn due to a treatment-related TEAE. This outcome is used to assess the tolerability of the study treatment.
Measured: Day 1 through Day 28
Frequency of TEAEs
The number of participants who experienced at least one TEAE of any severity. This outcome is used to assess the tolerability of the study treatment.
Measured: Day 1 through Day 28
Frequency of Grade 3 or Higher Laboratory AEs
The number of participants who experienced at least one Grade 3 (severe) or higher laboratory AE. This outcome is used to assess the tolerability of the study treatment.
Measured: Day 1 through Day 28
Frequency of Grade 3 or Higher Vital Signs AEs
The number of participants who experienced at least one Grade 3 (severe) or higher vital signs AE. This outcome is used to assess the tolerability of the study treatment.
Measured: Day 1 through Day 28
Frequency of Grade 3 or Higher ECG AEs
The number of participants who experienced at least one Grade 3 (severe) or higher ECG AE. This outcome is used to assess the tolerability of the study treatment.
Measured: Day 1 through Day 28
Frequency of Participants Who Received All Oral Medication Doses
The number of participants who received all doses of study product. This outcome is used to assess the tolerability of the study treatment.
Measured: Day 1 through Day 28
Secondary outcomes (29)
Maximum Concentration (Cmax) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Minimum Concentration (Cmin) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Time of Maximum Concentration (Tmax) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Time of Minimum Concentration (Tmin) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to Infinity (AUC0-inf) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. AUC0-inf was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: 0 h through 12 h post dose 1
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to 12 h (AUC0-12) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to the Last Concentration Above the Lower Limit of Quantitation (AUC0-last) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to the End of the Dosing Interval (AUC0-tau) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Terminal Half-Life (t1/2) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. t1/2 was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: 0 h through 12 h post dose 1
Total Clearance (CLT) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. CLT was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: 0 h through 12 h post dose 1
Terminal Phase Elimination Rate Constant (Ke) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. Ke was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: 0 h through 12 h post dose 1
Volume of Distribution (Vd) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis. Vd was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: 0 h through 12 h post dose 1
Dose-normalized AUC0-Tau (AUC0-tau/Dose) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Dose-normalized Cmax (Cmax/Dose) of SLV213 in Plasma After Dose 1
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1
Cmax at Steady State (Cmax,ss) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Cmin at Steady State (Cmin,ss) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Average Concentration During the Dosing Interval (Cavg) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Tmax at Steady State (Tmax,ss) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Tmin at Steady State (Tmin,ss) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to 48 h at Steady State (AUC0-48,ss) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
AUC0-tau at Steady State (AUC0-tau,ss) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
t1/2 of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. t1/2 was estimated for parameters meeting the following lambda-z acceptance criteria: rsq_adjusted (adjusted r squared) >= 0.90 and includes at least 3 time points after Tmax.
Measured: 0 h through 48 h post dose 14
CLT at Steady State (CLT,ss) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Vd at Steady State (Vd,ss) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Dose-Normalized AUC0-tau,ss (AUC0-tau,ss/Dose) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Dose-Normalized Cmax,ss (Cmax,ss/Dose) of SLV213 in Plasma After Dose 14
PK parameters were estimated from the SLV213 plasma concentration-time data after dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis. The estimate assumes steady state has been achieved.
Measured: 0 h through 48 h post dose 14
Linearity Index of SLV213 in Plasma
Linearity index is estimated as AUC0-tau,ss (Dose 14)/AUC0-inf (Dose 1). PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 and dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14
Accumulation Ratio for AUC (RAUC) of SLV213 in Plasma
RAUC is estimated as AUC0-tau,ss (Dose 14)/AUC0-tau (Dose 1). PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 and dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14
Accumulation Ratio for Cmax (RCmax) of SLV213 in Plasma
RCmax is estimated as Cmax,ss (Dose 14)/Cmax (Dose 1). PK parameters were estimated from the SLV213 plasma concentration-time data after dose 1 and dose 14 (the last dose) using Phoenix WinNonlin Non-compartmental analysis.
Measured: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start9 Apr 2024
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Why it stopped: DMID unanimously arrived at a recommendation to terminate the study after study met cohort halting criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146374
- Sponsor's protocol ID
- 22-0027
- Other IDs
- 75N93022D00016
- Status last verified
- 26 Dec 2023
- First submitted
- 22 Nov 2023
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose, Phase 1 Study of SLV213 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06146374
- Acronym / sponsor ID
- 22-0027
- Conditions
- COVID-19
- Keywords
- Coronavirus, Covid-19, Double Blind, Healthy Volunteers, Multiple Ascending Dose, Phase 1, Placebo Controlled, Randomized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DMID unanimously arrived at a recommendation to terminate the study after study met cohort halting criteria.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Posted 22 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 double blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses (MAD) of SLV213 in healthy male and female participants, 18-65 years of age. This study will help to select the most likely suitable dose (e.g., at Maximum Tolerated Dose [MTD]) for the treatment of patients with COVID-19 in a pivotal study. This phase 1 double blind, placebo-controlled study will consist of three sequential cohorts of 12 participants each (8 SLV213 and 4 placebo), at doses of 400 mg every 12 hours (Q12h), 600 mg Q12h, and 800 mg Q12h administered orally (PO) for 7 days. After each cohort, a Safety Review Committee (SRC) will evaluate the safety of the regimen before proceeding to dose the next cohort. Randomization will occur into the respective cohorts as above. Upon meeting the Inclusion/Exclusion criteria, subjects will begin treatment with SLV213 or placebo per their assigned cohort. The primary objective is to evaluate the safety and tolerability of multiple ascending doses of SLV213 for 7 days in healthy participants.
Detailed description
This Phase 1 double blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses (MAD) of SLV213 in healthy male and female participants, 18-65 years of age. This study will help to select the most likely suitable dose (e.g., at Maximum Tolerated Dose [MTD]) for the treatment of patients with COVID-19 in a pivotal study. This phase 1 double blind, placebo-controlled study will consist of three sequential cohorts of 12 participants each (8 SLV213 and 4 placebo), at doses of 400 mg every 12 hours (Q12h), 600 mg Q12h, and 800 mg Q12h administered orally (PO) for 7 days. After each cohort, a Safety Review Committee (SRC) will evaluate the safety of the regimen before proceeding to dose the next cohort. Randomization will occur into the respective cohorts as above. Upon meeting the Inclusion/Exclusion criteria, subjects will begin treatment with SLV213 or placebo per their assigned cohort. Participants will take their study drug in the fasted state prior to morning and evening meals and will remain as in-patient in the clinical trial unit (CTU) during all treatments and for approximately 48 hours (h) after the last dose for monitoring. After discharge from the CTU, participants will be monitored by CTU staff by telephone to assess for new adverse events and use of concomitant medication since the last visit or contact, approximately weekly for three weeks. Participants will be asked to return to the CTU for further assessment of moderate or severe adverse events (AEs) use of concomitant medications (ConMeds) since the last visit or contact, approximately weekly for three weeks. The primary objective is to evaluate the safety and tolerability of multiple ascending doses of SLV213 for 7 days in healthy participants. The secondary objective is to characterize the multiple dose PK of SLV213 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Other: Placebo for SLV213, Drug: SLV213600mg (6x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age. |
| Group 3 | Experimental | Other: Placebo for SLV213, Drug: SLV213800mg (8x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age. |
| Group1 | Experimental | Other: Placebo for SLV213, Drug: SLV213400mg (4x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provision of signed and dated informed consent form.
- Able to understand and willing to be available for all study visits and comply with all study procedures including Lifestyle Considerations throughout the study.
- Male and Female individuals, age 18-65 inclusive at time of enrollment.
- Good general health by medical history (MH), physical examination (PE), and vital signs (VS), clinical laboratory tests and Electrocardiogram (ECG) within normal reference range.
- Note 1: Lab exceptions include: lab test values that are within Grade 1 range per the Toxicity Table (Appendix A) are acceptable if not considered to be clinically significant by the investigator (PI, sub-investigator, or authorized clinician), with the exception of liver function tests (LFT) (transaminases Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), alkaline phosphatase (AP), total and direct bilirubin, serum creatinine, estimated glomerular filtration rate (eGFR) per the CKD-EPI formula, and urine protein, which must be within the laboratory normal reference range.
Key exclusion criteria (26 listed)
- Pregnant or lactating.
- History of any chronic disease that may increase risk to subject or interfere with endpoint assessment1:
- Note 1: With the exception of stable chronic medical conditions that do not require prescribed oral or injectable medications (e.g., Type 2 diabetes managed by diet only).
- History of bradycardia, orthostatic hypotension or orthostatic tachycardia, Long COVID or history of dysautonomia.1 Note 1: Exception is sinus bradycardia (HR <60 bpm) in healthy participants (e.g., conditioned athletes) could be enrolled per investigator's clinical judgement.
- Known history of a clinically significant food or drug allergy/hypersensitivity including known allergy/hypersensitivity to ingredients of the study drug or placebo.
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 |
|---|---|---|
| Placebo for SLV213Microcrystalline cellulose in a size 1 orange hard gelatin capsule. | Other | Group 2, Group 3, Group1 |
| SLV213SLV213 drug substance (K777) is 4-methylpiperazine-1-carboxylic acid, a vinyl sulfone cysteine protease inhibitor for the treatment of subjects infected with SARS-CoV-2. SLV213 is a white powder substance without excipients or stabilizer that will be packed into gelatin capsules which has been demonstrated to exhibit broad inhibitory properties against host cathepsins (e.g., Cathepsin L). | Drug | Group 2, Group 3, Group1 |
Primary outcome
Frequency of Treatment-Emergent Adverse Events (TEAEs) by Maximum Severity
Time frame: Day 1 through Day 28
The number of participants who experienced at least one unsolicited TEAE of any relatedness are summarized by the maximum severity recorded. A TEAE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as a TEAE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as a TEAE.
Frequency of Related Treatment-Related TEAEs
Time frame: Day 1 through Day 28
The number of participants who experienced at least one related unsolicited TEAE of any severity. A TEAE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. A TEAE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product. Any medical condition that was present at screening was considered a baseline finding and not reported as a TEAE. However, if the severity (i.e., grade) of any pre-existing medical condition increases, it was recorded as a TEAE. A TEAE is considered related if there is a reasonable possibility that the study intervention caused the TEAE, or there is a temporal relationship between the study intervention and event.
Frequency of Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 28
The number of participants who experienced at least one SAE throughout the course of the study. An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: * Death * A life-threatening adverse event * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or * A congenital anomaly/birth defect.
Frequency of Laboratory AEs by Maximum Severity
Time frame: Day 1 through Day 28
The number of participants who experienced at least one laboratory AE of any relatedness are summarized by the maximum severity recorded. Graded chemistry measurements include sodium, potassium, carbon dioxide, calcium, creatinine, blood urea nitrogen, fasting glucose, total protein, albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, amylase, lipase, magnesium, and inorganic phosphorous. Graded hematology measurements include hemoglobin, platelets, white blood cells, neutrophils, lymphocytes, monocytes, basophils, and eosinophils. Graded coagulation measurements include prothrombin time and activated partial thromboplastin time. Graded urinalysis measurements include nitrite, urine protein, urine glucose, white blood cells, red blood cells, and bacteria. If a laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Frequency of Treatment-Related Laboratory AEs
Time frame: Day 1 through Day 28
The number of participants who experienced at least one related laboratory AE of any severity. Graded chemistry measurements include sodium, potassium, carbon dioxide, calcium, creatinine, blood urea nitrogen, fasting glucose, total protein, albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, amylase, lipase, magnesium, and inorganic phosphorous. Graded hematology measurements include hemoglobin, platelets, white blood cells, neutrophils, lymphocytes, monocytes, basophils, and eosinophils. Graded coagulation measurements include prothrombin time and activated partial thromboplastin time. Graded urinalysis measurements include nitrite, urine protein, urine glucose, white blood cells, red blood cells, and bacteria. If a laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Frequency of Electrocardiogram (ECG) AEs by Maximum Severity
Time frame: Day 1 through Day 28
The number of participants who experienced at least one ECG AE of any relatedness are summarized by the maximum severity recorded. Graded ECG parameters include PR Internal and QTcF Interval.
Frequency of Treatment-Related ECG AEs
Time frame: Day 1 through Day 28
The number of participants who experienced at least one related ECG AE of any severity. Graded ECG parameters include PR Internal and QTcF Interval.
Frequency of Early Terminations or Withdrawals Due to Treatment-Related TEAEs
Time frame: Day 1 through Day 28
The number of participants who terminated early or were withdrawn due to a treatment-related TEAE. This outcome is used to assess the tolerability of the study treatment.
Frequency of TEAEs
Time frame: Day 1 through Day 28
The number of participants who experienced at least one TEAE of any severity. This outcome is used to assess the tolerability of the study treatment.
Frequency of Grade 3 or Higher Laboratory AEs
Time frame: Day 1 through Day 28
The number of participants who experienced at least one Grade 3 (severe) or higher laboratory AE. This outcome is used to assess the tolerability of the study treatment.
Frequency of Grade 3 or Higher Vital Signs AEs
Time frame: Day 1 through Day 28
The number of participants who experienced at least one Grade 3 (severe) or higher vital signs AE. This outcome is used to assess the tolerability of the study treatment.
Frequency of Grade 3 or Higher ECG AEs
Time frame: Day 1 through Day 28
The number of participants who experienced at least one Grade 3 (severe) or higher ECG AE. This outcome is used to assess the tolerability of the study treatment.
Frequency of Participants Who Received All Oral Medication Doses
Time frame: Day 1 through Day 28
The number of participants who received all doses of study product. This outcome is used to assess the tolerability of the study treatment.
29 secondary outcomes
Maximum Concentration (Cmax) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Minimum Concentration (Cmin) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Time of Maximum Concentration (Tmax) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Time of Minimum Concentration (Tmin) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to Infinity (AUC0-inf) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to 12 h (AUC0-12) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to the Last Concentration Above the Lower Limit of Quantitation (AUC0-last) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to the End of the Dosing Interval (AUC0-tau) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Terminal Half-Life (t1/2) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Total Clearance (CLT) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Terminal Phase Elimination Rate Constant (Ke) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Volume of Distribution (Vd) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Dose-normalized AUC0-Tau (AUC0-tau/Dose) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Dose-normalized Cmax (Cmax/Dose) of SLV213 in Plasma After Dose 1
Time frame: 0 h through 12 h post dose 1
Cmax at Steady State (Cmax,ss) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Cmin at Steady State (Cmin,ss) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Average Concentration During the Dosing Interval (Cavg) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Tmax at Steady State (Tmax,ss) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Tmin at Steady State (Tmin,ss) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Area Under the Concentration-Time Curve From 0 h (Pre-Dose) to 48 h at Steady State (AUC0-48,ss) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
AUC0-tau at Steady State (AUC0-tau,ss) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
t1/2 of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
CLT at Steady State (CLT,ss) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Vd at Steady State (Vd,ss) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Dose-Normalized AUC0-tau,ss (AUC0-tau,ss/Dose) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Dose-Normalized Cmax,ss (Cmax,ss/Dose) of SLV213 in Plasma After Dose 14
Time frame: 0 h through 48 h post dose 14
Linearity Index of SLV213 in Plasma
Time frame: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14
Accumulation Ratio for AUC (RAUC) of SLV213 in Plasma
Time frame: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14
Accumulation Ratio for Cmax (RCmax) of SLV213 in Plasma
Time frame: 0 h through 12 h post dose 1, 0 h through 48 h post dose 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 SLV213 in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 15 inclusion and 26 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: stopped early, as of the sponsor's last update on 22 Jul 2025. 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. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Treatment-Emergent Adverse Events (TEAEs) by Maximum Severity (time frame: Day 1 through Day 28). The study lists 13 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 22 Jul 2025.