Healthy SubjectsPhase 1NCT05298046
Study of TAVO101 in Healthy Volunteers
A Phase 1 study testing Experimental: TAVO101 in people with Healthy Subjects, run by Tavotek Biotherapeutics at 1 site in Australia.
Trial summary
This is a Phase 1, single ascending dose study designed to investigate TAVO101, administered as an IV infusion in healthy subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO101. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Experimental: TAVO101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 11 May 2022to 30 Sep 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 and ≤ 65 years of age, inclusive.
- Subjects must have a body weight range of ≥50 kg and≤100 kg, inclusive, and BMI ≥ 18.0 and ≤ 30.0 kg/m2, inclusive at Screening and Day-1.
- Subjects must be healthy based on clinical laboratory tests performed at Screening and Day-1.
- Females of childbearing potential who are sexually active with a male partner must agree to use a highly effective method of contraception from Screening through 196 days after the final dose of study drug.
- Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from Screening through 196 days, after administration of the last dose of study drug and their partners must be willing to use a highly effective method of contraception from Screening through 196 days after the last dose of study drug.
- Males must agree to not donate sperm from Screening through 196 days, after the last dose of study drug administration.
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- Subjects may be social smokers, defined as <5 cigarettes/month in last 6 months and must have negative cotinine test at Screening and check-in.
- Subjects will be considered eligible according to the following tuberculosis screening criteria's.
- Subjects must sign an Informed Consent Form.
Who cannot join
- Positive pregnancy test at Screening or baseline or is lactating.
- History or presence of conditions which, in the judgment of the investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History or presence of conditions that may place the subject at increased risk as determined by the investigator.
- Subject has clinically significant laboratory abnormalities, or other clinically significant findings in the opinion of the investigator.
- Subject currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject.
- Subject has a QT corrected according to Fridericia's formula (QTcF) interval >450 msec (for males) or >470 msec (for females), has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for Torsades de Pointes.
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- History of surgery or major trauma within 16 weeks of Screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study, or within 17 weeks after the last dose of study drug administration.
- Subject plans to undergo non-major elective surgery within 5 weeks prior to study drug administration through EOS.
- Subject has a known or suspected intolerance or hypersensitivity to any components of the formulation of TAVO101 and its excipients used in this study.
- Subject has known hypersensitivity or severe allergies to food and or medication of clinical significance in the opinion of the investigator.
- History of alcohol abuse (i.e., more than 3 drinks per day), illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of Screening.
- Use of prescription medications (including hormone replacement therapy) within 14 days prior to administration of the study drug. By exception, prescription drugs, such as hormonal birth control, will be permitted.
- Use of over-the-counter drugs (including herbal preparations) within 7 days or 5 half-lives (if known), whichever is longer, prior to administration of the study drug.
- Has received a vaccination within 14 days prior to administration of the study drug.
- Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity.
- Significant blood loss (>450mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation.
- Strenuous activity within 48 hours prior to CRU admission.
- Consumption of alcohol or caffeine-containing food or beverages within 48 hours prior to CRU admission.
- Positive urine drugs of abuse, alcohol, or cotinine screen.
- Positive test for HIV-1 or HIV-2 antibodies.
- Positive test for hepatitis B virus or hepatitis C virus consistent with current infection.
- Subject has liver function tests> 1.5x upper limit of normal (i.e., AST, ALT).
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAVO101 in Adult Healthy Subjects
This is a Phase 1, single ascending dose study designed to investigate TAVO101, administered as an IV infusion in healthy subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO101.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), single site study. Six subjects will be enrolled into each of the 7 dosing cohorts. Subjects will be randomized at a ratio of 2:1 to receive TAVO101 or placebo. Two sentinel subjects will be utilized (1 active:1 placebo) in each cohort in a manner designed to maintain the blind. Subjects will be evaluated for safety throughout the study up through day 196.
- Conditions
- Healthy Subjects
- Being tested
- Experimental: TAVO101, Other: Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: TAVO101Drug
Also called TAVO101
TAVO101 single ascending dose IV infusion.
Other: PlaceboOther
Placebo single ascending dose IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| TAVO101: Low dose | Experimental | TAVO101: TAVO101 single ascending dose IV infusion. Receives: Drug: Experimental: TAVO101 |
| TAVO101: Medium dose | Experimental | TAVO101: TAVO101 single ascending dose IV infusion. Receives: Drug: Experimental: TAVO101 |
| TAVO101: High dose | Experimental | TAVO101: TAVO101 single ascending dose IV infusion. Receives: Drug: Experimental: TAVO101 |
| Placebo | Placebo comparator | Placebo single ascending dose IV infusion. Receives: Other: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of adverse effects according to the National Cancer Institute's Common Terminology Criteria for AEs, Version 5.0 [Time Frame: Day 1 through Day 196]
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Measured: 196 days
Changes in vital signs including oral temperature or tympanic temperature (C°) [Time Frame: Day 1 through Day 196]
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Measured: 196 days
Changes in vital signs including respiratory rate (breaths per minute) [Time Frame: Day 1 through Day 196]
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Measured: 196 days
Changes in vital signs including systolic and diastolic blood pressure (mmHg) [Time Frame: Day 1 through Day 196]
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Measured: 196 days
Changes in vital signs including pulse rate (beats per minute) [Time Frame: Day 1 through Day 196]
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Measured: 196 days
Secondary outcomes (10)
Immunogenicity of TAVO101 [ Time Frame: Day 1 through Day 196 ]
Incidence of anti-drug antibodies (ADA) following dosing of TAVO101
Measured: 196 days
Cmax (Maximum observed serum concentration ) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
tmax (time that Cmax was observed) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
AUC-last (Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration; calculated using the linear/log trapezoid rule) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
AUC-inf (Area under the serum concentration-time curve from time 0 extrapolated to infinity) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
AUC0-t (Area under the serum concentration-time curve from time 0 to time t) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
t½ (Terminal elimination half-life) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
λz (Terminal elimination rate constant) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
CL (Systemic clearance) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
Vd (Volume of distribution) [ Time Frame: Day 1 through Day 196 ]
To investigate the pharmacokinetics of TAVO101 in healthy volunteers.
Measured: 196 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start11 May 2022
- Primary completion1 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tavotek Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298046
- Sponsor's protocol ID
- 59870001
- Status last verified
- Nov 2024
- First submitted
- 29 Dec 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAVO101 in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT05298046
- Acronym / sponsor ID
- 59870001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tavotek BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 28 Mar 2022 (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 is a Phase 1, single ascending dose study designed to investigate TAVO101, administered as an IV infusion in healthy subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO101.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), single site study. Six subjects will be enrolled into each of the 7 dosing cohorts. Subjects will be randomized at a ratio of 2:1 to receive TAVO101 or placebo. Two sentinel subjects will be utilized (1 active:1 placebo) in each cohort in a manner designed to maintain the blind. Subjects will be evaluated for safety throughout the study up through day 196.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TAVO101: Low dose | Experimental | Drug: Experimental: TAVO101TAVO101: TAVO101 single ascending dose IV infusion. |
| TAVO101: Medium dose | Experimental | Drug: Experimental: TAVO101TAVO101: TAVO101 single ascending dose IV infusion. |
| TAVO101: High dose | Experimental | Drug: Experimental: TAVO101TAVO101: TAVO101 single ascending dose IV infusion. |
| Placebo | Placebo comparator | Other: Other: PlaceboPlacebo single ascending dose IV infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females ≥ 18 and ≤ 65 years of age, inclusive.
- Subjects must have a body weight range of ≥50 kg and≤100 kg, inclusive, and BMI ≥ 18.0 and ≤ 30.0 kg/m2, inclusive at Screening and Day-1.
- Subjects must be healthy based on clinical laboratory tests performed at Screening and Day-1.
- Females of childbearing potential who are sexually active with a male partner must agree to use a highly effective method of contraception from Screening through 196 days after the final dose of study drug.
- Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from Screening through 196 days, after administration of the last dose of study drug and their partners must be willing to use a highly effective method of contraception from Screening through 196 days after the last dose of study drug.
Key exclusion criteria (22 listed)
- Positive pregnancy test at Screening or baseline or is lactating.
- History or presence of conditions which, in the judgment of the investigator, are known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History or presence of conditions that may place the subject at increased risk as determined by the investigator.
- Subject has clinically significant laboratory abnormalities, or other clinically significant findings in the opinion of the investigator.
- Subject currently has or has had a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject.
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 |
|---|---|---|
| Experimental: TAVO101Also: TAVO101TAVO101 single ascending dose IV infusion. | Drug | TAVO101: High dose, TAVO101: Low dose, TAVO101: Medium dose |
| Other: PlaceboPlacebo single ascending dose IV infusion. | Other | Placebo |
Primary outcome
The severity of adverse effects according to the National Cancer Institute's Common Terminology Criteria for AEs, Version 5.0 [Time Frame: Day 1 through Day 196]
Time frame: 196 days
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Changes in vital signs including oral temperature or tympanic temperature (C°) [Time Frame: Day 1 through Day 196]
Time frame: 196 days
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Changes in vital signs including respiratory rate (breaths per minute) [Time Frame: Day 1 through Day 196]
Time frame: 196 days
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Changes in vital signs including systolic and diastolic blood pressure (mmHg) [Time Frame: Day 1 through Day 196]
Time frame: 196 days
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
Changes in vital signs including pulse rate (beats per minute) [Time Frame: Day 1 through Day 196]
Time frame: 196 days
To investigate the safety and tolerability of TAVO101 in healthy volunteers.
10 secondary outcomes
Immunogenicity of TAVO101 [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
Cmax (Maximum observed serum concentration ) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
tmax (time that Cmax was observed) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
AUC-last (Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration; calculated using the linear/log trapezoid rule) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
AUC-inf (Area under the serum concentration-time curve from time 0 extrapolated to infinity) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
AUC0-t (Area under the serum concentration-time curve from time 0 to time t) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
t½ (Terminal elimination half-life) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
λz (Terminal elimination rate constant) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
CL (Systemic clearance) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
Vd (Volume of distribution) [ Time Frame: Day 1 through Day 196 ]
Time frame: 196 days
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 19 Nov 2024.
- 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 Experimental: TAVO101 in people with Healthy Subjects, run by Tavotek Biotherapeutics at 1 site in Australia.
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 9 inclusion and 22 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 19 Nov 2024. 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 Australia. 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?
The severity of adverse effects according to the National Cancer Institute's Common Terminology Criteria for AEs, Version 5.0 [Time Frame: Day 1 through Day 196] (time frame: 196 days). The study lists 5 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 19 Nov 2024.