Study of TAVO103A in Healthy Volunteers

NCT ID: NCT05313152

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2023-06-08

Brief Summary

This is a Phase 1, single ascending dose study designed to investigate TAVO103A, administered as an IV infusion up to 60 minutes in length to healthy adult subjects. This study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAVO103A.

Detailed Description

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), single site study. There will be up to 5 SAD cohorts with 6 subjects enrolled into each. Subjects will be randomized at a ratio of 2:1 to receive TAVO103A or placebo. Subjects will be evaluated for safety throughout the study up through day 196.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

TAVO103A Low Dose

TAVO103A: TAVO103A single ascending dose IV infusion.

Group Type: EXPERIMENTAL

TAVO103A

Intervention Type: DRUG

TAVO103A single ascending dose IV infusion.

TAVO10A Medium Dose

TAVO103A: TAVO103A single ascending dose IV infusion.

Group Type: EXPERIMENTAL

TAVO103A

Intervention Type: DRUG

TAVO103A single ascending dose IV infusion.

TAVO103A High Dose

TAVO103A: TAVO103A single ascending dose IV infusion.

Group Type: EXPERIMENTAL

TAVO103A

Intervention Type: DRUG

TAVO103A single ascending dose IV infusion.

Placebo

Placebo single ascending dose IV infusion.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo single ascending dose IV infusion.

Interventions

TAVO103A

TAVO103A single ascending dose IV infusion.

Intervention Type: DRUG

Placebo

Placebo single ascending dose IV infusion.

Intervention Type: OTHER

Eligibility Criteria

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 a BMI ≥ 18.0 and ≤ 30.0 kg/m2, inclusive.
• 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 the end of the study.
• Males who are sexually active and nonsterile, and whose partners are females of childbearing potential must agree to use condoms from screening through the end of the study.
• Males must agree to not donate sperm from screening through the end of the study.
• Subjects must be able to communicate effectively with the study personnel.
• Subjects must be nonsmokers, defined as having abstained from tobacco- or nicotine-containing products in the 6 months prior to Screening.
• Subjects will be considered eligible according to the following tuberculosis screening criteria's.
• Subjects must sign an informed consent form.

Exclusion Criteria

• Positive pregnancy test or is lactating at any time during the study.
• 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 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 (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 4 weeks prior to study drug administration through EOS.
• Subject has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of TAVO103A and its excipients used in this study.
• History of alcohol abuse, 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 within 14 days or any drugs that induce or inhibit study drug-specific cytochrome 450(s) within 14 days or 5 half-lives (if known), whichever is longer, prior to administration of the study drug. By exception, prescription drugs, such as hormonal birth control or hormone replacement therapy, will be permitted.
• Use of OTC drugs (including herbal preparations) within 7 days or 5 half-lives (if known), whichever is longer, prior to administration of the study drug. Common OTC drugs are acceptable with investigator approval.
• Has received a vaccination within 30 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 (if known), whichever is longer, prior to administration of the study drug in this study or is currently participating in another clinical study.
• Significant blood loss (> 450 mL) 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 3 days prior to CRU admission
• Positive urine drugs of abuse, alcohol breath test, or cotinine screen at any time during the study.
• Positive test for HIV-1 or HIV-2 antibodies.
• Positive test for hepatitis B virus or hepatitis C virus consistent with current infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tavotek Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

59870002

Identifier Type: -

Identifier Source: org_study_id