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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05298046




Registration number
NCT05298046
Ethics application status
Date submitted
29/12/2021
Date registered
28/03/2022

Titles & IDs
Public title
Study of TAVO101 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
59870001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Experimental: TAVO101
Other interventions - Other: Placebo

Experimental: TAVO101: Low dose - TAVO101: TAVO101 single ascending dose IV infusion.

Experimental: TAVO101: Medium dose - TAVO101: TAVO101 single ascending dose IV infusion.

Experimental: TAVO101: High dose - TAVO101: TAVO101 single ascending dose IV infusion.

Placebo comparator: Placebo - Placebo single ascending dose IV infusion.


Treatment: Drugs: Experimental: TAVO101
TAVO101 single ascending dose IV infusion.

Other interventions: Other: Placebo
Placebo single ascending dose IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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]
Timepoint [1] 0 0
196 days
Primary outcome [2] 0 0
Changes in vital signs including oral temperature or tympanic temperature (C°) [Time Frame: Day 1 through Day 196]
Timepoint [2] 0 0
196 days
Primary outcome [3] 0 0
Changes in vital signs including respiratory rate (breaths per minute) [Time Frame: Day 1 through Day 196]
Timepoint [3] 0 0
196 days
Primary outcome [4] 0 0
Changes in vital signs including systolic and diastolic blood pressure (mmHg) [Time Frame: Day 1 through Day 196]
Timepoint [4] 0 0
196 days
Primary outcome [5] 0 0
Changes in vital signs including pulse rate (beats per minute) [Time Frame: Day 1 through Day 196]
Timepoint [5] 0 0
196 days
Secondary outcome [1] 0 0
Immunogenicity of TAVO101 [ Time Frame: Day 1 through Day 196 ]
Timepoint [1] 0 0
196 days
Secondary outcome [2] 0 0
Cmax (Maximum observed serum concentration ) [ Time Frame: Day 1 through Day 196 ]
Timepoint [2] 0 0
196 days
Secondary outcome [3] 0 0
tmax (time that Cmax was observed) [ Time Frame: Day 1 through Day 196 ]
Timepoint [3] 0 0
196 days
Secondary outcome [4] 0 0
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 ]
Timepoint [4] 0 0
196 days
Secondary outcome [5] 0 0
AUC-inf (Area under the serum concentration-time curve from time 0 extrapolated to infinity) [ Time Frame: Day 1 through Day 196 ]
Timepoint [5] 0 0
196 days
Secondary outcome [6] 0 0
AUC0-t (Area under the serum concentration-time curve from time 0 to time t) [ Time Frame: Day 1 through Day 196 ]
Timepoint [6] 0 0
196 days
Secondary outcome [7] 0 0
t½ (Terminal elimination half-life) [ Time Frame: Day 1 through Day 196 ]
Timepoint [7] 0 0
196 days
Secondary outcome [8] 0 0
?z (Terminal elimination rate constant) [ Time Frame: Day 1 through Day 196 ]
Timepoint [8] 0 0
196 days
Secondary outcome [9] 0 0
CL (Systemic clearance) [ Time Frame: Day 1 through Day 196 ]
Timepoint [9] 0 0
196 days
Secondary outcome [10] 0 0
Vd (Volume of distribution) [ Time Frame: Day 1 through Day 196 ]
Timepoint [10] 0 0
196 days

Eligibility
Key inclusion criteria
* 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.
* 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.
* 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2024
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tavotek Biotherapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05298046